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Jeffrey Weber, MD, PhD, Giant of Cancer Care, Dies
Dr. Weber, a melanoma and cancer immunotherapy specialist, served as deputy director of the Laura and Isaac Perlmutter Cancer Center at New York University (NYU) Langone Medical Center in New York City. He also held positions as the Laura and Isaac Perlmutter Professor of Oncology in the Department of Medicine at the NYU Grossman School of Medicine, director of the Experimental Therapeutics Program, and co-leader of the Clinical Melanoma Program Board at NYU Langone Health.
Dr. Weber was a principal investigator on many studies, including pivotal clinical drug trials in melanoma and trials focused on managing autoimmune side effects from immunotherapy. He published more than 150 articles in top peer-reviewed journals.
For many years, Dr. Weber hosted the popular “Weber on Oncology” series of video contributions for Medscape Oncology, sharing updates and insights on noteworthy research and breakthroughs in melanoma.
“The Melanoma Research Alliance mourns the passing of Dr. Jeffrey S. Weber, a true pioneer in the field of cancer immunotherapy and an extraordinary leader in melanoma research. His contributions have forever changed the landscape of melanoma treatment, bringing groundbreaking advances from the lab into clinical practice and offering hope to countless patients,” the Melanoma Research Alliance posted on LinkedIn.
Many X users also shared condolences and memories of Dr. Weber, praising his numerous contributions and accomplishments.
“[Cancer Research Institute] mourns the loss of Dr. Jeffrey S. Weber ... [a]s an accomplished physician scientist, Dr. Weber drove advances in melanoma research, and played an active role in educating patients about the lifesaving power of immunotherapy,” the Cancer Research Institute posted.
A colleague noted that “[h]e was involved in the early days of cytokine and cell therapy and most recently led studies of personalized vaccines for melanoma patients. ... He was a great friend and colleague to many of us in the melanoma and immunotherapy field and we will remember him as a pioneer, thought leader and compassionate physician.”
A version of this article first appeared on Medscape.com.
Dr. Weber, a melanoma and cancer immunotherapy specialist, served as deputy director of the Laura and Isaac Perlmutter Cancer Center at New York University (NYU) Langone Medical Center in New York City. He also held positions as the Laura and Isaac Perlmutter Professor of Oncology in the Department of Medicine at the NYU Grossman School of Medicine, director of the Experimental Therapeutics Program, and co-leader of the Clinical Melanoma Program Board at NYU Langone Health.
Dr. Weber was a principal investigator on many studies, including pivotal clinical drug trials in melanoma and trials focused on managing autoimmune side effects from immunotherapy. He published more than 150 articles in top peer-reviewed journals.
For many years, Dr. Weber hosted the popular “Weber on Oncology” series of video contributions for Medscape Oncology, sharing updates and insights on noteworthy research and breakthroughs in melanoma.
“The Melanoma Research Alliance mourns the passing of Dr. Jeffrey S. Weber, a true pioneer in the field of cancer immunotherapy and an extraordinary leader in melanoma research. His contributions have forever changed the landscape of melanoma treatment, bringing groundbreaking advances from the lab into clinical practice and offering hope to countless patients,” the Melanoma Research Alliance posted on LinkedIn.
Many X users also shared condolences and memories of Dr. Weber, praising his numerous contributions and accomplishments.
“[Cancer Research Institute] mourns the loss of Dr. Jeffrey S. Weber ... [a]s an accomplished physician scientist, Dr. Weber drove advances in melanoma research, and played an active role in educating patients about the lifesaving power of immunotherapy,” the Cancer Research Institute posted.
A colleague noted that “[h]e was involved in the early days of cytokine and cell therapy and most recently led studies of personalized vaccines for melanoma patients. ... He was a great friend and colleague to many of us in the melanoma and immunotherapy field and we will remember him as a pioneer, thought leader and compassionate physician.”
A version of this article first appeared on Medscape.com.
Dr. Weber, a melanoma and cancer immunotherapy specialist, served as deputy director of the Laura and Isaac Perlmutter Cancer Center at New York University (NYU) Langone Medical Center in New York City. He also held positions as the Laura and Isaac Perlmutter Professor of Oncology in the Department of Medicine at the NYU Grossman School of Medicine, director of the Experimental Therapeutics Program, and co-leader of the Clinical Melanoma Program Board at NYU Langone Health.
Dr. Weber was a principal investigator on many studies, including pivotal clinical drug trials in melanoma and trials focused on managing autoimmune side effects from immunotherapy. He published more than 150 articles in top peer-reviewed journals.
For many years, Dr. Weber hosted the popular “Weber on Oncology” series of video contributions for Medscape Oncology, sharing updates and insights on noteworthy research and breakthroughs in melanoma.
“The Melanoma Research Alliance mourns the passing of Dr. Jeffrey S. Weber, a true pioneer in the field of cancer immunotherapy and an extraordinary leader in melanoma research. His contributions have forever changed the landscape of melanoma treatment, bringing groundbreaking advances from the lab into clinical practice and offering hope to countless patients,” the Melanoma Research Alliance posted on LinkedIn.
Many X users also shared condolences and memories of Dr. Weber, praising his numerous contributions and accomplishments.
“[Cancer Research Institute] mourns the loss of Dr. Jeffrey S. Weber ... [a]s an accomplished physician scientist, Dr. Weber drove advances in melanoma research, and played an active role in educating patients about the lifesaving power of immunotherapy,” the Cancer Research Institute posted.
A colleague noted that “[h]e was involved in the early days of cytokine and cell therapy and most recently led studies of personalized vaccines for melanoma patients. ... He was a great friend and colleague to many of us in the melanoma and immunotherapy field and we will remember him as a pioneer, thought leader and compassionate physician.”
A version of this article first appeared on Medscape.com.
Alert System Could Warn of Impact of Severe Weather on Health
As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.
Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.
The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.
For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.
The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.
For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.
In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”
These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.
Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
Health Alerts Have Potential, But Comprehensive Approach is Needed
“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.
A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.
“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.
However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.
Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.
Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
A version of this article first appeared on Medscape.com.
As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.
Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.
The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.
For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.
The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.
For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.
In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”
These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.
Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
Health Alerts Have Potential, But Comprehensive Approach is Needed
“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.
A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.
“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.
However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.
Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.
Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
A version of this article first appeared on Medscape.com.
As more data show potentially dangerous effects of climate and weather on individuals with chronic medical conditions, CVS Health has introduced an initiative that uses technology to provide weather alerts and targeted outreach to those at increased risk, according to a press release from the company. Ultimately, the goals of the initiative are to improve health, reduce emergency department visits, hospital stays, and medical costs, according to the press release.
Extreme weather events such as heat waves are becoming more frequent and severe, but most heat-related deaths are preventable with outreach and intervention, Dan Knecht, MD, vice president and chief clinical innovation officer for CVS Caremark, a division of CVS Health, said in an interview. The approach will combine the company’s services, including care managers, health centers, and data, to aid patients vulnerable to severe weather.
The initiative is starting with a focus on extreme heat events and will expand this fall with alerts about high levels of air pollution for individuals with vulnerability to reduced lung function, asthma, and cardiac problems as a result of exposure to high air-pollution levels, according to Dr. Knecht.
For now, the initiative is available to members of Aetna Medicare, according to Dr. Knecht. “Our goal is to expand to other consumers, including those who visit MinuteClinic and CVS Pharmacy locations, where we can provide timely environment-related recommendations at time of care,” he said.
The alert system uses environmental data analytics to pair highly localized forecasts and real-time insights about air quality, wildfires, and high heat with medical and pharmacy data for high-risk patients in areas affected by extreme weather.
For example, for individuals who are at risk and living in areas facing extreme heat, “registered nurse care managers proactively reach out to vulnerable patients up to several days in advance of an extreme weather event and provide them personalized tips and resources,” said Dr. Knecht.
In addition, he added, “we talk to patients about how to manage their medications during periods of extreme heat and, when delivering medications, take weather data into account to determine appropriate packaging materials for shipments.”
These interventions direct patients to CVS Health–linked resources, such as Oak Street Health clinics available as cooling centers, health services provided at MinuteClinic locations, and medication management at CVS pharmacies. Other interventions include virtual or in-person mental health counseling through MinuteClinic.
Dr. Knecht offered additional guidance for clinicians and patients to help manage heat waves. “Heat and certain medications can impair heat tolerance and the ability to regulate body temperature,” he told this news organization. Extreme heat may affect the performance of some medications and their devices, such as inhalers and diabetes supplies, he added.
Health Alerts Have Potential, But Comprehensive Approach is Needed
“Patients with chronic lung conditions are highly susceptible to the impact of climate change,” MeiLan K. Han, MD, a pulmonologist and professor of internal medicine at the University of Michigan, Ann Arbor, said in an interview. “Increasing dust, hotter temperatures, and higher levels of air pollution make it more difficult for patients to breathe,” she said. Data also suggest that higher levels of air pollution may not only cause chronic lung disease but also cause worsening symptoms among those with existing disease, she added.
A weather-related health alert could be useful for patients so they can be prepared, Dr. Han told this news organization.
“For a patient with chronic lung disease, a hot weather alert may mean that it will be harder for patients to breathe, and [they] may [be] more susceptible to heat stroke and dehydration if they do not have access to air conditioning,” she said. “At a minimum, patients should ensure they are on their controller medications, which often means a daily inhaler for patients with conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, patients also should have access to their short-term reliever medications so they can be prepared for increased shortness of breath that may accompany a hot weather day,” Dr. Han explained.
However, not all patients have access to technology such as smartphones or other devices that will alert them to impending weather events, such as heat waves, said Dr. Han. “For these patients, a standard phone call may be beneficial,” she said.
Looking ahead, “programs for weather-related health alerts will need to be comprehensive, focusing not only on access to needed medications but also climate-controlled settings for temporary relief of heat,” said Dr. Han. “For some of our most vulnerable patients, while they may have air conditioning, they may not be able to afford to run it, so this needs to be considered in developing a comprehensive program,” she emphasized.
Dr. Knecht had no financial conflicts to disclose. Dr. Han disclosed ties with Aerogen, Altesa BioSciences, American Lung Association, Amgen, Apreo Health, AstraZeneca, Biodesix, Boehringer Ingelheim, Chiesi, Cipla, COPD Foundation, DevPro, Gala Therapeutics, Genentech, GlaxoSmithKline, Integrity, MDBriefcase, Medscape, Medtronic, Medwiz, Meissa Vaccines, Merck, Mylan, NACE, National Institutes of Health, Novartis, Nuvaira, Polarian, Pulmonx, Regeneron, Roche, RS Biotherapeutics, Sanofi, Sunovion, Teva, UpToDate, and Verona..
A version of this article first appeared on Medscape.com.
Clinical Controversy: Watch-and-Wait or Surgery in Rectal Cancer Near Complete Responders?
Having an ostomy is a dreaded prospect for many patients with rectal cancer.
To defer, and potentially avoid, this life-altering surgery,
About 80% of these patients who have a complete clinical response — a perfectly healed scar where the tumor used to be and other favorable features — can forgo total mesorectal excision and preserve their rectum.
The success of watch-and-wait among complete responders has led some centers to offer the approach in patients with near-complete responses to neoadjuvant chemoradiation.
But watch-and-wait for near-complete clinical responders “is very controversial,” Alan P. Venook, MD, a gastrointestinal oncologist at the University of California, San Francisco (UCSF), told this news organization.
“You sure as hell don’t want to miss a chance to cure a patient,” Dr. Venook said.
A near-complete clinical response essentially means there is no sign of the tumor 8 weeks after total neoadjuvant therapy, but the tumor bed hasn’t completely healed.
The goal of watch-and-wait in this scenario is to give near-complete response lesions time to become complete responses.
But there’s no clear way to predict which tumors will evolve into a clinical complete response.
Recent studies evaluating the conversion rate have reported that anywhere from 39% to about 90% of near-complete responders became complete responders. Some of the variation likely comes down to differences in the clinical stage of patients evaluated in each study as well as the limited number of patients who achieve a near-complete response overall.
Other concerns have emerged that waiting for near-complete responses to become complete leaves extra time for some tumors to metastasize and that tumor regrowth is much higher compared with complete responders.
A recent study found that 13% of near-complete responders who preserved their rectum on watch-and-wait developed distant metastases vs about 5% of long-term complete responders. The study also found that just over half of near-complete responders have tumor regrowth compared with about one in five complete responders.
But even with regrowth, “surgery is still curative,” explained Julio Garcia-Aguilar, MD, PhD, a pioneer of watch-and-wait for rectal cancer.
And overall, around 50%-60% of patients with a near-complete response can avoid surgery and preserve their rectum.
Selecting Patients for Watch-and-Wait
The key to deciding which patients are right for watch-and-wait is to understand how a near-complete clinical response was defined in the OPRA trial, a landmark randomized trial led by Dr. Garcia-Aguilar that helped establish watch-and-wait as an option in rectal cancer.
OPRA defined a near-complete response as no visible tumor but, in the tumor bed, mild erythema, superficial ulceration, minor mucosal abnormality or small nodules, and an irregular mucosa. The criteria also included no palpable tumor with smooth induration or a minor mucosal abnormality on the digital rectal exam.
The National Comprehensive Cancer Network mirrored the definition when, for the first time, it recommended watch-and-wait as an option for near-complete response in its 2023 rectal cancer guidelines. The group also added a few MRI requirements.
UCSF offers the watch-and-wait option to some patients with near-complete responses, but each decision is made on a case-by-case basis by a tumor board considering numerous measures of tumor aggressiveness.
Even then, “we have, in many cases, struggled to figure out what the right choices are,” Dr. Venook said.
For those chosen for watch-and-wait, Dr. Venook noted that UCSF has top-notch surgeons, radiation oncologists, medical oncologists, and pathologists who have the resources to follow patients closely.
For community practices without the resources of a major cancer center, watch-and-wait for near-complete response to rectal cancer “is really asking a lot,” Dr. Venook said.
Dr. Garcia-Aguilar, a colorectal surgeon at Memorial Sloan Kettering Cancer Center in New York City, explained that after years of studying the issue, he is comfortable with watch-and-wait in near-complete responders as long as it’s done carefully and in patients who will comply with ongoing surveillance.
Dr. Garcia-Aguilar explained that, after diagnosing a near-complete response 8 weeks following total neoadjuvant therapy, the patient needs to come back 6 weeks later. At that point, it’s time to assess whether that near-complete response is evolving into a complete response or not evolving into a complete response.
If it’s evolving into a complete response, surveillance continues about every 8 weeks, but if the tumor has stopped responding, “you take [the patient] to the operating room,” Dr. Garcia-Aguilar said.
As for the bigger safety concern — that near clinical complete response tumors will metastasize — Dr. Garcia-Aguilar’s opinion is that micrometastases are probably already there when the rectal cancer is first diagnosed and will manifest themselves “no matter what happens to the primary tumor.”
Because of that, he noted, “I don’t think the risk is very high” when surgery is delayed a few months to give near-complete response patients a chance to keep their rectum.
The way to answer the metastasis question is to do a randomized trial pitting surgery against watch-and-wait in patients with near-clinical complete response rectal cancer.
However, Dr. Garcia-Aguilar doesn’t think that trial will ever happen. Patients won’t allow themselves to be randomized to surgery once they find out they might be able to avoid a permanent ostomy, he said.
Dr. Venook had no disclosures. Dr. Garcia-Aguilar reported personal fees from Medtronic, Johnson & Johnson, and Intuitive Surgical.
A version of this article first appeared on Medscape.com.
Having an ostomy is a dreaded prospect for many patients with rectal cancer.
To defer, and potentially avoid, this life-altering surgery,
About 80% of these patients who have a complete clinical response — a perfectly healed scar where the tumor used to be and other favorable features — can forgo total mesorectal excision and preserve their rectum.
The success of watch-and-wait among complete responders has led some centers to offer the approach in patients with near-complete responses to neoadjuvant chemoradiation.
But watch-and-wait for near-complete clinical responders “is very controversial,” Alan P. Venook, MD, a gastrointestinal oncologist at the University of California, San Francisco (UCSF), told this news organization.
“You sure as hell don’t want to miss a chance to cure a patient,” Dr. Venook said.
A near-complete clinical response essentially means there is no sign of the tumor 8 weeks after total neoadjuvant therapy, but the tumor bed hasn’t completely healed.
The goal of watch-and-wait in this scenario is to give near-complete response lesions time to become complete responses.
But there’s no clear way to predict which tumors will evolve into a clinical complete response.
Recent studies evaluating the conversion rate have reported that anywhere from 39% to about 90% of near-complete responders became complete responders. Some of the variation likely comes down to differences in the clinical stage of patients evaluated in each study as well as the limited number of patients who achieve a near-complete response overall.
Other concerns have emerged that waiting for near-complete responses to become complete leaves extra time for some tumors to metastasize and that tumor regrowth is much higher compared with complete responders.
A recent study found that 13% of near-complete responders who preserved their rectum on watch-and-wait developed distant metastases vs about 5% of long-term complete responders. The study also found that just over half of near-complete responders have tumor regrowth compared with about one in five complete responders.
But even with regrowth, “surgery is still curative,” explained Julio Garcia-Aguilar, MD, PhD, a pioneer of watch-and-wait for rectal cancer.
And overall, around 50%-60% of patients with a near-complete response can avoid surgery and preserve their rectum.
Selecting Patients for Watch-and-Wait
The key to deciding which patients are right for watch-and-wait is to understand how a near-complete clinical response was defined in the OPRA trial, a landmark randomized trial led by Dr. Garcia-Aguilar that helped establish watch-and-wait as an option in rectal cancer.
OPRA defined a near-complete response as no visible tumor but, in the tumor bed, mild erythema, superficial ulceration, minor mucosal abnormality or small nodules, and an irregular mucosa. The criteria also included no palpable tumor with smooth induration or a minor mucosal abnormality on the digital rectal exam.
The National Comprehensive Cancer Network mirrored the definition when, for the first time, it recommended watch-and-wait as an option for near-complete response in its 2023 rectal cancer guidelines. The group also added a few MRI requirements.
UCSF offers the watch-and-wait option to some patients with near-complete responses, but each decision is made on a case-by-case basis by a tumor board considering numerous measures of tumor aggressiveness.
Even then, “we have, in many cases, struggled to figure out what the right choices are,” Dr. Venook said.
For those chosen for watch-and-wait, Dr. Venook noted that UCSF has top-notch surgeons, radiation oncologists, medical oncologists, and pathologists who have the resources to follow patients closely.
For community practices without the resources of a major cancer center, watch-and-wait for near-complete response to rectal cancer “is really asking a lot,” Dr. Venook said.
Dr. Garcia-Aguilar, a colorectal surgeon at Memorial Sloan Kettering Cancer Center in New York City, explained that after years of studying the issue, he is comfortable with watch-and-wait in near-complete responders as long as it’s done carefully and in patients who will comply with ongoing surveillance.
Dr. Garcia-Aguilar explained that, after diagnosing a near-complete response 8 weeks following total neoadjuvant therapy, the patient needs to come back 6 weeks later. At that point, it’s time to assess whether that near-complete response is evolving into a complete response or not evolving into a complete response.
If it’s evolving into a complete response, surveillance continues about every 8 weeks, but if the tumor has stopped responding, “you take [the patient] to the operating room,” Dr. Garcia-Aguilar said.
As for the bigger safety concern — that near clinical complete response tumors will metastasize — Dr. Garcia-Aguilar’s opinion is that micrometastases are probably already there when the rectal cancer is first diagnosed and will manifest themselves “no matter what happens to the primary tumor.”
Because of that, he noted, “I don’t think the risk is very high” when surgery is delayed a few months to give near-complete response patients a chance to keep their rectum.
The way to answer the metastasis question is to do a randomized trial pitting surgery against watch-and-wait in patients with near-clinical complete response rectal cancer.
However, Dr. Garcia-Aguilar doesn’t think that trial will ever happen. Patients won’t allow themselves to be randomized to surgery once they find out they might be able to avoid a permanent ostomy, he said.
Dr. Venook had no disclosures. Dr. Garcia-Aguilar reported personal fees from Medtronic, Johnson & Johnson, and Intuitive Surgical.
A version of this article first appeared on Medscape.com.
Having an ostomy is a dreaded prospect for many patients with rectal cancer.
To defer, and potentially avoid, this life-altering surgery,
About 80% of these patients who have a complete clinical response — a perfectly healed scar where the tumor used to be and other favorable features — can forgo total mesorectal excision and preserve their rectum.
The success of watch-and-wait among complete responders has led some centers to offer the approach in patients with near-complete responses to neoadjuvant chemoradiation.
But watch-and-wait for near-complete clinical responders “is very controversial,” Alan P. Venook, MD, a gastrointestinal oncologist at the University of California, San Francisco (UCSF), told this news organization.
“You sure as hell don’t want to miss a chance to cure a patient,” Dr. Venook said.
A near-complete clinical response essentially means there is no sign of the tumor 8 weeks after total neoadjuvant therapy, but the tumor bed hasn’t completely healed.
The goal of watch-and-wait in this scenario is to give near-complete response lesions time to become complete responses.
But there’s no clear way to predict which tumors will evolve into a clinical complete response.
Recent studies evaluating the conversion rate have reported that anywhere from 39% to about 90% of near-complete responders became complete responders. Some of the variation likely comes down to differences in the clinical stage of patients evaluated in each study as well as the limited number of patients who achieve a near-complete response overall.
Other concerns have emerged that waiting for near-complete responses to become complete leaves extra time for some tumors to metastasize and that tumor regrowth is much higher compared with complete responders.
A recent study found that 13% of near-complete responders who preserved their rectum on watch-and-wait developed distant metastases vs about 5% of long-term complete responders. The study also found that just over half of near-complete responders have tumor regrowth compared with about one in five complete responders.
But even with regrowth, “surgery is still curative,” explained Julio Garcia-Aguilar, MD, PhD, a pioneer of watch-and-wait for rectal cancer.
And overall, around 50%-60% of patients with a near-complete response can avoid surgery and preserve their rectum.
Selecting Patients for Watch-and-Wait
The key to deciding which patients are right for watch-and-wait is to understand how a near-complete clinical response was defined in the OPRA trial, a landmark randomized trial led by Dr. Garcia-Aguilar that helped establish watch-and-wait as an option in rectal cancer.
OPRA defined a near-complete response as no visible tumor but, in the tumor bed, mild erythema, superficial ulceration, minor mucosal abnormality or small nodules, and an irregular mucosa. The criteria also included no palpable tumor with smooth induration or a minor mucosal abnormality on the digital rectal exam.
The National Comprehensive Cancer Network mirrored the definition when, for the first time, it recommended watch-and-wait as an option for near-complete response in its 2023 rectal cancer guidelines. The group also added a few MRI requirements.
UCSF offers the watch-and-wait option to some patients with near-complete responses, but each decision is made on a case-by-case basis by a tumor board considering numerous measures of tumor aggressiveness.
Even then, “we have, in many cases, struggled to figure out what the right choices are,” Dr. Venook said.
For those chosen for watch-and-wait, Dr. Venook noted that UCSF has top-notch surgeons, radiation oncologists, medical oncologists, and pathologists who have the resources to follow patients closely.
For community practices without the resources of a major cancer center, watch-and-wait for near-complete response to rectal cancer “is really asking a lot,” Dr. Venook said.
Dr. Garcia-Aguilar, a colorectal surgeon at Memorial Sloan Kettering Cancer Center in New York City, explained that after years of studying the issue, he is comfortable with watch-and-wait in near-complete responders as long as it’s done carefully and in patients who will comply with ongoing surveillance.
Dr. Garcia-Aguilar explained that, after diagnosing a near-complete response 8 weeks following total neoadjuvant therapy, the patient needs to come back 6 weeks later. At that point, it’s time to assess whether that near-complete response is evolving into a complete response or not evolving into a complete response.
If it’s evolving into a complete response, surveillance continues about every 8 weeks, but if the tumor has stopped responding, “you take [the patient] to the operating room,” Dr. Garcia-Aguilar said.
As for the bigger safety concern — that near clinical complete response tumors will metastasize — Dr. Garcia-Aguilar’s opinion is that micrometastases are probably already there when the rectal cancer is first diagnosed and will manifest themselves “no matter what happens to the primary tumor.”
Because of that, he noted, “I don’t think the risk is very high” when surgery is delayed a few months to give near-complete response patients a chance to keep their rectum.
The way to answer the metastasis question is to do a randomized trial pitting surgery against watch-and-wait in patients with near-clinical complete response rectal cancer.
However, Dr. Garcia-Aguilar doesn’t think that trial will ever happen. Patients won’t allow themselves to be randomized to surgery once they find out they might be able to avoid a permanent ostomy, he said.
Dr. Venook had no disclosures. Dr. Garcia-Aguilar reported personal fees from Medtronic, Johnson & Johnson, and Intuitive Surgical.
A version of this article first appeared on Medscape.com.
Research Promises Better Diabetic Retinopathy Management
STOCKHOLM — At the American Society of Retina Specialists (ASRS) 2024 Annual Meeting, researchers discussed how insights into potential risk factors and new treatments could improve outcomes for patients with diabetic retinopathy.
Jennifer Lim, MD, an ophthalmologist and director of the Retina Service at the University of Illinois Hospital & Health Sciences System in Chicago, told this news organization that emerging approaches to treating diabetic retinopathy offer hope because they address the root causes of the disease beyond just targeting vascular endothelial growth factor (VEGF). She said innovative methods and add-on treatments could lead to more durable and effective drugs.
Exploration of risk factors and treatment options for diabetic retinopathy could lead to more effective management strategies for the condition, agreed David Boyer, MD, an ophthalmologist at Retina Vitreous Associates Medical Group in Los Angeles, speaking with this news organization.
Risk Factors for Diabetic Retinopathy
Sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have gained popularity because of their benefits beyond glycemic control, including weight loss, and cardiovascular and kidney protection. However, the impact of these medications on vision-threatening retinal complications is not fully understood. “There has always been a question about whether these newer diabetes medications might exacerbate diabetic eye disease,” said Dr. Boyer.
In a retrospective observational study, researchers included adults with type 2 diabetes and moderate cardiovascular disease risk who had no history of advanced diabetic retinal complications. These patients initiated treatment with GLP-1 RA, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas. The study used inverse probability of treatment weighting to mimic randomization and compared the time to the first treatment for diabetic macular edema or proliferative diabetic retinopathy across the treatment groups.
Results, presented by Andrew J. Barkmeier, MD, an associate professor of ophthalmology at the Mayo Clinic, showed that among 371,698 patients, those who initiated therapy with SGLT2 inhibitors had a lower risk of requiring treatment for sight-threatening retinopathy compared with those using other medication classes. GLP-1 RA did not increase retinopathy risk relative to dipeptidyl peptidase 4 inhibitors and sulfonylurea medications.
“[This study] told us that we do have to keep an eye on patients’ retinopathy when they start on these new inhibitors. But the progression is minimal and, overall, I think most people today favor keeping blood sugar levels as good as possible,” said Dr. Boyer, who was not involved in the study.
Another factor that might increase diabetic retinopathy progression is obstructive sleep apnea. This underdiagnosed condition is linked to several health issues, including dementia, stroke, and myocardial infarctions. Although not easily treated, obstructive sleep apnea is manageable, Dr. Boyer explained.
Researchers utilized the TriNetX electronic health records research network to identify patients with nonproliferative diabetic retinopathy, both with and without obstructive sleep apnea.
The results, presented by Ehsan Rahimy, MD, a retinal specialist at Palo Alto Medical Foundation and a professor at Stanford University, showed that patients with obstructive sleep apnea had a significantly higher risk of progressing to proliferative diabetic retinopathy and developing new-onset diabetic macular edema. These patients were more likely to require ocular interventions, such as intravitreal injections and laser photocoagulation. They also had greater risks for stroke, myocardial infarction, and death compared with those who did not have obstructive sleep apnea.
“It was good to bring this to everybody’s attention,” said Dr. Boyer, who was not involved in the study. “It’s an easy question to ask someone if they snore.”
New Treatments on the Horizon
In another presentation, Nathan C. Steinle, MD, of California Retina Consultants, presented a study that assessed the durability of response to sozinibercept in patients with retinal vascular diseases. This novel therapeutic agent is designed to inhibit VEGF-C and VEGF-D in conditions where VEGF-A suppression alone is insufficient.
Sozinibercept was combined with standard anti–VEGF-A therapies such as ranibizumab or aflibercept. It involved a prospective, post hoc analysis of two phase 1b, open-label, dose-escalation studies, including 40 patients with neovascular age-related macular degeneration (nAMD; 31 patients) or diabetic macular edema (nine patients). These patients, either treatment-naive or previously treated, received three intravitreal injections of ranibizumab or aflibercept in combination with sozinibercept at various doses.
Results indicated that sozinibercept combination therapy was well tolerated, with no dose-limiting toxicities. In treatment-naive nAMD patients, the mean best-corrected visual acuity (BCVA) improved significantly from baseline at months 3 and 6. Previously treated nAMD patients also showed BCVA improvements, although to a lesser extent. For patients with persistent diabetic macular edema, switching to sozinibercept plus aflibercept resulted in notable BCVA gains. The mean time to requiring retreatment was longer in treatment-naive patients than in those previously treated, indicating a durable response.
“Combination therapy with sozinibercept is going to be really important,” said Dr. Lim, who was not involved in the study, “because it attacks with a dual mechanism of action.”
Oral agents promise a potentially easier alternative for patients compared with frequent injections. CU06-1004 is a novel orally administered endothelial dysfunction blocker that has shown promise in stabilizing damaged capillaries, reducing abnormal angiogenesis, and inhibiting inflammatory activation in preclinical studies. “CU06 is very interesting to me because by preventing endothelial loss, it gets to the pathophysiology of why the blood vessels break down,” Dr. Lim said.
In a proof-of-concept phase 2a, multicenter, open-label, parallel-group trial, investigators randomly assigned 67 patients with diabetic macular edema to receive 100 mg, 200 mg, or 300 mg of CU06-1004 once daily for 12 weeks, followed by a 4-week follow-up.
Results presented by Victor Gonzalez, MD, of Valley Retina Institute in Texas, indicated that the oral agent improved BCVA, stabilized central subfield thickness, and showed positive anatomical changes in optical coherence tomography images. CU06-1004 was well tolerated, with no drug-related serious adverse events.
“The number [of patients] was very small, and we will need a much longer, larger trial to see if [CU06-1004] has benefits long term,” said Dr. Boyer, who was not involved in the study. “But I think we’re all very excited if we can find an oral agent for treating diabetic retinopathy. It would be easier for the patient to take a pill than having to come in for injections.”
The sustained-release axitinib implant, OTX-TKI, is also generating significant interest, particularly for nonproliferative diabetic retinopathy. Axitinib, a tyrosine kinase inhibitor (TKI), targets signaling pathways crucial in cellular processes, providing a novel approach to managing diseases where traditional therapies might fall short. Unlike traditional anti-VEGF treatments that focus solely on cytokine levels, TKIs block the activation of signaling pathways, preventing downstream signaling regardless of cytokine levels. This mechanism is particularly important because it effectively inhibits disease progression even if levels of VEGF are high, Dr. Lim explained.
In the phase 1 HELIOS trial, OTX-TKI was assessed in patients with nonproliferative diabetic retinopathy. This multicenter, double-masked, parallel-group clinical study included 21 patients who had not received anti-VEGF treatment, dexamethasone intravitreal implants in the previous 12 months, or intraocular steroid injections in the prior 4 months. Patients were randomly assigned to receive either OTX-TKI or sham treatment.
Results presented by Dilsher S. Dhoot, MD, of California Retina Consultants, indicated that OTX-TKI was generally well tolerated, with no serious ocular adverse events. At 48 weeks, 46.2% of eyes treated with OTX-TKI showed a 1- or 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) compared with none in the sham arm. Additionally, no eyes treated with OTX-TKI experienced a worsening on the DRSS, whereas 25% of eyes in the sham arm did. Vision-threatening complications, such as proliferative diabetic retinopathy or diabetic macular edema, developed in 37.5% of the sham group but in none of the OTX-TKI treated eyes. A single injection of OTX-TKI provided durable DRSS improvement for up to 48 weeks, with no patients in either arm requiring rescue therapy.
“This is a really exciting add-on treatment,” Dr. Lim said, who was not involved in the study. She explained that it is initially necessary to control the disease with standard treatments, because TKIs may take longer to exhibit their effects. Once the disease is stabilized, TKIs can be used alongside other therapies, potentially reducing the reliance on frequent anti-VEGF injections. “These are preliminary results, but that’s the hope going forward.”
Dr. Lim and Dr. Boyer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM — At the American Society of Retina Specialists (ASRS) 2024 Annual Meeting, researchers discussed how insights into potential risk factors and new treatments could improve outcomes for patients with diabetic retinopathy.
Jennifer Lim, MD, an ophthalmologist and director of the Retina Service at the University of Illinois Hospital & Health Sciences System in Chicago, told this news organization that emerging approaches to treating diabetic retinopathy offer hope because they address the root causes of the disease beyond just targeting vascular endothelial growth factor (VEGF). She said innovative methods and add-on treatments could lead to more durable and effective drugs.
Exploration of risk factors and treatment options for diabetic retinopathy could lead to more effective management strategies for the condition, agreed David Boyer, MD, an ophthalmologist at Retina Vitreous Associates Medical Group in Los Angeles, speaking with this news organization.
Risk Factors for Diabetic Retinopathy
Sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have gained popularity because of their benefits beyond glycemic control, including weight loss, and cardiovascular and kidney protection. However, the impact of these medications on vision-threatening retinal complications is not fully understood. “There has always been a question about whether these newer diabetes medications might exacerbate diabetic eye disease,” said Dr. Boyer.
In a retrospective observational study, researchers included adults with type 2 diabetes and moderate cardiovascular disease risk who had no history of advanced diabetic retinal complications. These patients initiated treatment with GLP-1 RA, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas. The study used inverse probability of treatment weighting to mimic randomization and compared the time to the first treatment for diabetic macular edema or proliferative diabetic retinopathy across the treatment groups.
Results, presented by Andrew J. Barkmeier, MD, an associate professor of ophthalmology at the Mayo Clinic, showed that among 371,698 patients, those who initiated therapy with SGLT2 inhibitors had a lower risk of requiring treatment for sight-threatening retinopathy compared with those using other medication classes. GLP-1 RA did not increase retinopathy risk relative to dipeptidyl peptidase 4 inhibitors and sulfonylurea medications.
“[This study] told us that we do have to keep an eye on patients’ retinopathy when they start on these new inhibitors. But the progression is minimal and, overall, I think most people today favor keeping blood sugar levels as good as possible,” said Dr. Boyer, who was not involved in the study.
Another factor that might increase diabetic retinopathy progression is obstructive sleep apnea. This underdiagnosed condition is linked to several health issues, including dementia, stroke, and myocardial infarctions. Although not easily treated, obstructive sleep apnea is manageable, Dr. Boyer explained.
Researchers utilized the TriNetX electronic health records research network to identify patients with nonproliferative diabetic retinopathy, both with and without obstructive sleep apnea.
The results, presented by Ehsan Rahimy, MD, a retinal specialist at Palo Alto Medical Foundation and a professor at Stanford University, showed that patients with obstructive sleep apnea had a significantly higher risk of progressing to proliferative diabetic retinopathy and developing new-onset diabetic macular edema. These patients were more likely to require ocular interventions, such as intravitreal injections and laser photocoagulation. They also had greater risks for stroke, myocardial infarction, and death compared with those who did not have obstructive sleep apnea.
“It was good to bring this to everybody’s attention,” said Dr. Boyer, who was not involved in the study. “It’s an easy question to ask someone if they snore.”
New Treatments on the Horizon
In another presentation, Nathan C. Steinle, MD, of California Retina Consultants, presented a study that assessed the durability of response to sozinibercept in patients with retinal vascular diseases. This novel therapeutic agent is designed to inhibit VEGF-C and VEGF-D in conditions where VEGF-A suppression alone is insufficient.
Sozinibercept was combined with standard anti–VEGF-A therapies such as ranibizumab or aflibercept. It involved a prospective, post hoc analysis of two phase 1b, open-label, dose-escalation studies, including 40 patients with neovascular age-related macular degeneration (nAMD; 31 patients) or diabetic macular edema (nine patients). These patients, either treatment-naive or previously treated, received three intravitreal injections of ranibizumab or aflibercept in combination with sozinibercept at various doses.
Results indicated that sozinibercept combination therapy was well tolerated, with no dose-limiting toxicities. In treatment-naive nAMD patients, the mean best-corrected visual acuity (BCVA) improved significantly from baseline at months 3 and 6. Previously treated nAMD patients also showed BCVA improvements, although to a lesser extent. For patients with persistent diabetic macular edema, switching to sozinibercept plus aflibercept resulted in notable BCVA gains. The mean time to requiring retreatment was longer in treatment-naive patients than in those previously treated, indicating a durable response.
“Combination therapy with sozinibercept is going to be really important,” said Dr. Lim, who was not involved in the study, “because it attacks with a dual mechanism of action.”
Oral agents promise a potentially easier alternative for patients compared with frequent injections. CU06-1004 is a novel orally administered endothelial dysfunction blocker that has shown promise in stabilizing damaged capillaries, reducing abnormal angiogenesis, and inhibiting inflammatory activation in preclinical studies. “CU06 is very interesting to me because by preventing endothelial loss, it gets to the pathophysiology of why the blood vessels break down,” Dr. Lim said.
In a proof-of-concept phase 2a, multicenter, open-label, parallel-group trial, investigators randomly assigned 67 patients with diabetic macular edema to receive 100 mg, 200 mg, or 300 mg of CU06-1004 once daily for 12 weeks, followed by a 4-week follow-up.
Results presented by Victor Gonzalez, MD, of Valley Retina Institute in Texas, indicated that the oral agent improved BCVA, stabilized central subfield thickness, and showed positive anatomical changes in optical coherence tomography images. CU06-1004 was well tolerated, with no drug-related serious adverse events.
“The number [of patients] was very small, and we will need a much longer, larger trial to see if [CU06-1004] has benefits long term,” said Dr. Boyer, who was not involved in the study. “But I think we’re all very excited if we can find an oral agent for treating diabetic retinopathy. It would be easier for the patient to take a pill than having to come in for injections.”
The sustained-release axitinib implant, OTX-TKI, is also generating significant interest, particularly for nonproliferative diabetic retinopathy. Axitinib, a tyrosine kinase inhibitor (TKI), targets signaling pathways crucial in cellular processes, providing a novel approach to managing diseases where traditional therapies might fall short. Unlike traditional anti-VEGF treatments that focus solely on cytokine levels, TKIs block the activation of signaling pathways, preventing downstream signaling regardless of cytokine levels. This mechanism is particularly important because it effectively inhibits disease progression even if levels of VEGF are high, Dr. Lim explained.
In the phase 1 HELIOS trial, OTX-TKI was assessed in patients with nonproliferative diabetic retinopathy. This multicenter, double-masked, parallel-group clinical study included 21 patients who had not received anti-VEGF treatment, dexamethasone intravitreal implants in the previous 12 months, or intraocular steroid injections in the prior 4 months. Patients were randomly assigned to receive either OTX-TKI or sham treatment.
Results presented by Dilsher S. Dhoot, MD, of California Retina Consultants, indicated that OTX-TKI was generally well tolerated, with no serious ocular adverse events. At 48 weeks, 46.2% of eyes treated with OTX-TKI showed a 1- or 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) compared with none in the sham arm. Additionally, no eyes treated with OTX-TKI experienced a worsening on the DRSS, whereas 25% of eyes in the sham arm did. Vision-threatening complications, such as proliferative diabetic retinopathy or diabetic macular edema, developed in 37.5% of the sham group but in none of the OTX-TKI treated eyes. A single injection of OTX-TKI provided durable DRSS improvement for up to 48 weeks, with no patients in either arm requiring rescue therapy.
“This is a really exciting add-on treatment,” Dr. Lim said, who was not involved in the study. She explained that it is initially necessary to control the disease with standard treatments, because TKIs may take longer to exhibit their effects. Once the disease is stabilized, TKIs can be used alongside other therapies, potentially reducing the reliance on frequent anti-VEGF injections. “These are preliminary results, but that’s the hope going forward.”
Dr. Lim and Dr. Boyer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
STOCKHOLM — At the American Society of Retina Specialists (ASRS) 2024 Annual Meeting, researchers discussed how insights into potential risk factors and new treatments could improve outcomes for patients with diabetic retinopathy.
Jennifer Lim, MD, an ophthalmologist and director of the Retina Service at the University of Illinois Hospital & Health Sciences System in Chicago, told this news organization that emerging approaches to treating diabetic retinopathy offer hope because they address the root causes of the disease beyond just targeting vascular endothelial growth factor (VEGF). She said innovative methods and add-on treatments could lead to more durable and effective drugs.
Exploration of risk factors and treatment options for diabetic retinopathy could lead to more effective management strategies for the condition, agreed David Boyer, MD, an ophthalmologist at Retina Vitreous Associates Medical Group in Los Angeles, speaking with this news organization.
Risk Factors for Diabetic Retinopathy
Sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have gained popularity because of their benefits beyond glycemic control, including weight loss, and cardiovascular and kidney protection. However, the impact of these medications on vision-threatening retinal complications is not fully understood. “There has always been a question about whether these newer diabetes medications might exacerbate diabetic eye disease,” said Dr. Boyer.
In a retrospective observational study, researchers included adults with type 2 diabetes and moderate cardiovascular disease risk who had no history of advanced diabetic retinal complications. These patients initiated treatment with GLP-1 RA, SGLT2 inhibitors, DPP-4 inhibitors, or sulfonylureas. The study used inverse probability of treatment weighting to mimic randomization and compared the time to the first treatment for diabetic macular edema or proliferative diabetic retinopathy across the treatment groups.
Results, presented by Andrew J. Barkmeier, MD, an associate professor of ophthalmology at the Mayo Clinic, showed that among 371,698 patients, those who initiated therapy with SGLT2 inhibitors had a lower risk of requiring treatment for sight-threatening retinopathy compared with those using other medication classes. GLP-1 RA did not increase retinopathy risk relative to dipeptidyl peptidase 4 inhibitors and sulfonylurea medications.
“[This study] told us that we do have to keep an eye on patients’ retinopathy when they start on these new inhibitors. But the progression is minimal and, overall, I think most people today favor keeping blood sugar levels as good as possible,” said Dr. Boyer, who was not involved in the study.
Another factor that might increase diabetic retinopathy progression is obstructive sleep apnea. This underdiagnosed condition is linked to several health issues, including dementia, stroke, and myocardial infarctions. Although not easily treated, obstructive sleep apnea is manageable, Dr. Boyer explained.
Researchers utilized the TriNetX electronic health records research network to identify patients with nonproliferative diabetic retinopathy, both with and without obstructive sleep apnea.
The results, presented by Ehsan Rahimy, MD, a retinal specialist at Palo Alto Medical Foundation and a professor at Stanford University, showed that patients with obstructive sleep apnea had a significantly higher risk of progressing to proliferative diabetic retinopathy and developing new-onset diabetic macular edema. These patients were more likely to require ocular interventions, such as intravitreal injections and laser photocoagulation. They also had greater risks for stroke, myocardial infarction, and death compared with those who did not have obstructive sleep apnea.
“It was good to bring this to everybody’s attention,” said Dr. Boyer, who was not involved in the study. “It’s an easy question to ask someone if they snore.”
New Treatments on the Horizon
In another presentation, Nathan C. Steinle, MD, of California Retina Consultants, presented a study that assessed the durability of response to sozinibercept in patients with retinal vascular diseases. This novel therapeutic agent is designed to inhibit VEGF-C and VEGF-D in conditions where VEGF-A suppression alone is insufficient.
Sozinibercept was combined with standard anti–VEGF-A therapies such as ranibizumab or aflibercept. It involved a prospective, post hoc analysis of two phase 1b, open-label, dose-escalation studies, including 40 patients with neovascular age-related macular degeneration (nAMD; 31 patients) or diabetic macular edema (nine patients). These patients, either treatment-naive or previously treated, received three intravitreal injections of ranibizumab or aflibercept in combination with sozinibercept at various doses.
Results indicated that sozinibercept combination therapy was well tolerated, with no dose-limiting toxicities. In treatment-naive nAMD patients, the mean best-corrected visual acuity (BCVA) improved significantly from baseline at months 3 and 6. Previously treated nAMD patients also showed BCVA improvements, although to a lesser extent. For patients with persistent diabetic macular edema, switching to sozinibercept plus aflibercept resulted in notable BCVA gains. The mean time to requiring retreatment was longer in treatment-naive patients than in those previously treated, indicating a durable response.
“Combination therapy with sozinibercept is going to be really important,” said Dr. Lim, who was not involved in the study, “because it attacks with a dual mechanism of action.”
Oral agents promise a potentially easier alternative for patients compared with frequent injections. CU06-1004 is a novel orally administered endothelial dysfunction blocker that has shown promise in stabilizing damaged capillaries, reducing abnormal angiogenesis, and inhibiting inflammatory activation in preclinical studies. “CU06 is very interesting to me because by preventing endothelial loss, it gets to the pathophysiology of why the blood vessels break down,” Dr. Lim said.
In a proof-of-concept phase 2a, multicenter, open-label, parallel-group trial, investigators randomly assigned 67 patients with diabetic macular edema to receive 100 mg, 200 mg, or 300 mg of CU06-1004 once daily for 12 weeks, followed by a 4-week follow-up.
Results presented by Victor Gonzalez, MD, of Valley Retina Institute in Texas, indicated that the oral agent improved BCVA, stabilized central subfield thickness, and showed positive anatomical changes in optical coherence tomography images. CU06-1004 was well tolerated, with no drug-related serious adverse events.
“The number [of patients] was very small, and we will need a much longer, larger trial to see if [CU06-1004] has benefits long term,” said Dr. Boyer, who was not involved in the study. “But I think we’re all very excited if we can find an oral agent for treating diabetic retinopathy. It would be easier for the patient to take a pill than having to come in for injections.”
The sustained-release axitinib implant, OTX-TKI, is also generating significant interest, particularly for nonproliferative diabetic retinopathy. Axitinib, a tyrosine kinase inhibitor (TKI), targets signaling pathways crucial in cellular processes, providing a novel approach to managing diseases where traditional therapies might fall short. Unlike traditional anti-VEGF treatments that focus solely on cytokine levels, TKIs block the activation of signaling pathways, preventing downstream signaling regardless of cytokine levels. This mechanism is particularly important because it effectively inhibits disease progression even if levels of VEGF are high, Dr. Lim explained.
In the phase 1 HELIOS trial, OTX-TKI was assessed in patients with nonproliferative diabetic retinopathy. This multicenter, double-masked, parallel-group clinical study included 21 patients who had not received anti-VEGF treatment, dexamethasone intravitreal implants in the previous 12 months, or intraocular steroid injections in the prior 4 months. Patients were randomly assigned to receive either OTX-TKI or sham treatment.
Results presented by Dilsher S. Dhoot, MD, of California Retina Consultants, indicated that OTX-TKI was generally well tolerated, with no serious ocular adverse events. At 48 weeks, 46.2% of eyes treated with OTX-TKI showed a 1- or 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) compared with none in the sham arm. Additionally, no eyes treated with OTX-TKI experienced a worsening on the DRSS, whereas 25% of eyes in the sham arm did. Vision-threatening complications, such as proliferative diabetic retinopathy or diabetic macular edema, developed in 37.5% of the sham group but in none of the OTX-TKI treated eyes. A single injection of OTX-TKI provided durable DRSS improvement for up to 48 weeks, with no patients in either arm requiring rescue therapy.
“This is a really exciting add-on treatment,” Dr. Lim said, who was not involved in the study. She explained that it is initially necessary to control the disease with standard treatments, because TKIs may take longer to exhibit their effects. Once the disease is stabilized, TKIs can be used alongside other therapies, potentially reducing the reliance on frequent anti-VEGF injections. “These are preliminary results, but that’s the hope going forward.”
Dr. Lim and Dr. Boyer report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASRS 2024
Experts Highlight Challenges That Remain for AI Devices in Triaging Skin Cancer
Emerging according to researchers and dermatologists investigating AI.
While some AI-integrated devices designed to triage skin lesions have emerged, including one that received Food and Drug Administration (FDA) clearance earlier in 2024, it may be some time before AI has a meaningful clinical impact in dermatology and, more specifically, the diagnosis of skin cancer, Ivy Lee, MD, a dermatologist in Pasadena, California, and chair of the American Academy of Dermatology’s augmented intelligence committee, told this news organization.
“It hasn’t really translated into clinical practice yet,” Dr. Lee said of AI in dermatology. “There have been significant advances in terms of the technical possibility and feasibility of these tools, but the translation and integration of AI into actual clinical work flows to benefit patients beyond academic research studies has been limited.” More studies and more “easily accessible and digestible information” are needed to evaluate AI tools in dermatologic practice.
“In dermatology, we’re on a cusp with AI,” said Rebecca Hartman, MD, MPH, chief of dermatology at the VA Boston Healthcare System and director of melanoma epidemiology at Brigham and Women’s Hospital, Boston, Massachusetts. “I think it’s going to come and change what we do,” which is especially true for any image-based specialty,” including radiology and pathology, in addition to dermatology.
Dr. Hartman led a study of one of these emerging technologies, the handheld elastic scattering spectroscopy device DermaSensor, which was cleared by the FDA in January for evaluating skin lesions suggestive of skin cancer.
Early AI Devices for Skin Cancer Detection
At the American Society for Laser Medicine and Surgery (ASLMS) meeting in April, a panel explored a number of algorithms with dermatologic applications that use AI to triage skin lesions, including DermaSensor.
Raman spectroscopy, which contains a handheld Raman probe, a diode laser, and a detecting spectrograph. A laser beam — which at 1.56 W/cm2 is below the maximum permissible exposure — focuses on the skin target with a 3.5-mm spot, gathers data on the target, and feeds it back into the unit that houses the algorithm that evaluates the spot analysis. It’s still in the investigative phase. A clinical trial, published almost 5 years ago, demonstrated a sensitivity of 90%-99% and a specificity of 24%-66% for skin cancer.
A dermatoscope called Sklip clips onto a smartphone and performs what company cofounder Alexander Witkowski, MD, PhD, described as an “optical painless virtual biopsy” for at-home use. The device uploads the captured image to an AI platform for analysis. It received FDA breakthrough device designation in 2022. At the ASLMS meeting, Dr. Witkowski said that clinical performance showed the device had a 97% sensitivity and 30% specificity for skin cancer.
DermaSensor, described in the study conducted by Dr. Hartman and others as a noninvasive, point-and-click spectrometer, is a wireless handheld piece that weighs about 10 ounces. The unit captures five recordings to generate a spectral reading, which an algorithm in the software unit analyzes. The study found a sensitivity of 95.5% and specificity of 32.5% for melanoma detection with the device.
The target market for DermaSensor is primary care physicians, and, according to the FDA announcement in January, it is indicated for evaluating skin lesions “suggestive” of melanoma, basal cell carcinoma (BCC), and/or squamous cell carcinoma (SCC) in patients aged 40 and older to “assist healthcare providers in determining whether to refer a patient to a dermatologist.”
So Many Cases, So Few Dermatologists
In dermatology, AI devices have the potential to streamline the crushing burden of diagnosing skin cancer, said Yun Liu, PhD, a senior staff scientist at Google Research, Mountain View, California, who’s worked on developing machine-learning tools in dermatology among other medical fields. “Many people cannot access dermatology expertise when they most need it, ie, without waiting a long time. This causes substantial morbidity for patients,” Dr. Liu said in an interview.
His own research of an AI-based tool to help primary care physicians and nurse practitioners in teledermatology practices diagnose skin conditions documented the shortage of dermatologists to triage lesions, including a finding that only about one quarter of skin conditions are seen by a specialist and that nonspecialists play a pivotal role in the management of skin lesions.
The Centers for Disease Control and Prevention reports that about 6.1 million adults are treated for BCC and SCCs each year. The American Medical Association estimates that 13,200 active dermatologists practice in the United States.
Overcoming Barriers to AI in Dermatology
Before AI makes significant inroads in dermatology, clinicians need to see more verifiable data, said Roxana Daneshjou, MD, PhD, assistant professor of biomedical data science and dermatology at Stanford University, Stanford, California. “One of the challenges is having the availability of models that actually improve clinical care because we have some very early prospective trials on different devices, but we don’t have large-scale randomized clinical trials of AI devices showing definitive behaviors such as improved patient outcomes, that it helps curb skin cancer, or it catches it like dermatologists but helps reduce the biopsy load,” she said. “You need good data.”
Another challenge she noted was overcoming biases built into medicine. “A lot of the image-based models are built on datasets depicting skin disease on White skin, and those models don’t work so well on people with brown and black skin, who have historically had worse outcomes and also have been underrepresented in dermatology,” said Dr. Daneshjou, an associate editor of NEJM AI.
There’s also the challenge of getting verified AI models into the clinic. “Similar to many medical AI endeavors, developing a proof-of-concept or research prototype is far easier and faster than bringing the development to real users,” Dr. Liu said. “In particular, it is important to conduct thorough validation studies on various patient populations and settings and understand how these AI tools can best fit into the workflow or patient journey.”
A study published in 2023 documented progress Google made in deploying AI models in retina specialty clinics in India and Thailand, Dr. Liu noted.
Another challenge is to avoid overdiagnosis with these new technologies, Dr. Hartman said. Her group’s study showed the DermaSensor had a positive predictive value of 16% and a negative predictive value of 98.5%. “I think there’s some question about how this will factor into overdiagnosis. Could this actually bombard dermatologists more if the positive predictive value’s only 16%?”
One key to dermatologists accepting AI tools is having a transparent process for validating them, Dr. Lee said. “Even with FDA clearance, we don’t have the transparency we need as clinicians, researchers, and advocates of machine learning and AI in healthcare.”
But, Dr. Lee noted, the FDA in June took a step toward illuminating its validation process when it adopted guiding principles for transparency for machine learning–enabled devices. “Once we can get more access to this information and have more transparency, that’s where we can think about actually about making the decision to implement or not implement into local healthcare settings,” she said. The process was further enabled by a White House executive order in October 2023 on the safe, secure, and trustworthy development and use of AI.
The experience with telehealth during the COVID-19 pandemic, when patients and providers quickly embraced the technology to stay connected, serves as a potential template for AI, Dr. Lee noted. “As we’d seen with telehealth through the pandemic, you also need the cultural evolution and the development of the infrastructure around it to actually make sure this is a sustainable implementation and a scalable implementation in healthcare.”
Dr. Lee had no relevant relationships to disclose. Dr. Hartman received funding from DermaSensor for a study. Dr. Witkowski is a cofounder of Sklip. Dr. Liu is an employee of Google Research. Dr. Daneshjou reported financial relationships with MD Algorithms, Revea, and L’Oreal.
A version of this article first appeared on Medscape.com.
Emerging according to researchers and dermatologists investigating AI.
While some AI-integrated devices designed to triage skin lesions have emerged, including one that received Food and Drug Administration (FDA) clearance earlier in 2024, it may be some time before AI has a meaningful clinical impact in dermatology and, more specifically, the diagnosis of skin cancer, Ivy Lee, MD, a dermatologist in Pasadena, California, and chair of the American Academy of Dermatology’s augmented intelligence committee, told this news organization.
“It hasn’t really translated into clinical practice yet,” Dr. Lee said of AI in dermatology. “There have been significant advances in terms of the technical possibility and feasibility of these tools, but the translation and integration of AI into actual clinical work flows to benefit patients beyond academic research studies has been limited.” More studies and more “easily accessible and digestible information” are needed to evaluate AI tools in dermatologic practice.
“In dermatology, we’re on a cusp with AI,” said Rebecca Hartman, MD, MPH, chief of dermatology at the VA Boston Healthcare System and director of melanoma epidemiology at Brigham and Women’s Hospital, Boston, Massachusetts. “I think it’s going to come and change what we do,” which is especially true for any image-based specialty,” including radiology and pathology, in addition to dermatology.
Dr. Hartman led a study of one of these emerging technologies, the handheld elastic scattering spectroscopy device DermaSensor, which was cleared by the FDA in January for evaluating skin lesions suggestive of skin cancer.
Early AI Devices for Skin Cancer Detection
At the American Society for Laser Medicine and Surgery (ASLMS) meeting in April, a panel explored a number of algorithms with dermatologic applications that use AI to triage skin lesions, including DermaSensor.
Raman spectroscopy, which contains a handheld Raman probe, a diode laser, and a detecting spectrograph. A laser beam — which at 1.56 W/cm2 is below the maximum permissible exposure — focuses on the skin target with a 3.5-mm spot, gathers data on the target, and feeds it back into the unit that houses the algorithm that evaluates the spot analysis. It’s still in the investigative phase. A clinical trial, published almost 5 years ago, demonstrated a sensitivity of 90%-99% and a specificity of 24%-66% for skin cancer.
A dermatoscope called Sklip clips onto a smartphone and performs what company cofounder Alexander Witkowski, MD, PhD, described as an “optical painless virtual biopsy” for at-home use. The device uploads the captured image to an AI platform for analysis. It received FDA breakthrough device designation in 2022. At the ASLMS meeting, Dr. Witkowski said that clinical performance showed the device had a 97% sensitivity and 30% specificity for skin cancer.
DermaSensor, described in the study conducted by Dr. Hartman and others as a noninvasive, point-and-click spectrometer, is a wireless handheld piece that weighs about 10 ounces. The unit captures five recordings to generate a spectral reading, which an algorithm in the software unit analyzes. The study found a sensitivity of 95.5% and specificity of 32.5% for melanoma detection with the device.
The target market for DermaSensor is primary care physicians, and, according to the FDA announcement in January, it is indicated for evaluating skin lesions “suggestive” of melanoma, basal cell carcinoma (BCC), and/or squamous cell carcinoma (SCC) in patients aged 40 and older to “assist healthcare providers in determining whether to refer a patient to a dermatologist.”
So Many Cases, So Few Dermatologists
In dermatology, AI devices have the potential to streamline the crushing burden of diagnosing skin cancer, said Yun Liu, PhD, a senior staff scientist at Google Research, Mountain View, California, who’s worked on developing machine-learning tools in dermatology among other medical fields. “Many people cannot access dermatology expertise when they most need it, ie, without waiting a long time. This causes substantial morbidity for patients,” Dr. Liu said in an interview.
His own research of an AI-based tool to help primary care physicians and nurse practitioners in teledermatology practices diagnose skin conditions documented the shortage of dermatologists to triage lesions, including a finding that only about one quarter of skin conditions are seen by a specialist and that nonspecialists play a pivotal role in the management of skin lesions.
The Centers for Disease Control and Prevention reports that about 6.1 million adults are treated for BCC and SCCs each year. The American Medical Association estimates that 13,200 active dermatologists practice in the United States.
Overcoming Barriers to AI in Dermatology
Before AI makes significant inroads in dermatology, clinicians need to see more verifiable data, said Roxana Daneshjou, MD, PhD, assistant professor of biomedical data science and dermatology at Stanford University, Stanford, California. “One of the challenges is having the availability of models that actually improve clinical care because we have some very early prospective trials on different devices, but we don’t have large-scale randomized clinical trials of AI devices showing definitive behaviors such as improved patient outcomes, that it helps curb skin cancer, or it catches it like dermatologists but helps reduce the biopsy load,” she said. “You need good data.”
Another challenge she noted was overcoming biases built into medicine. “A lot of the image-based models are built on datasets depicting skin disease on White skin, and those models don’t work so well on people with brown and black skin, who have historically had worse outcomes and also have been underrepresented in dermatology,” said Dr. Daneshjou, an associate editor of NEJM AI.
There’s also the challenge of getting verified AI models into the clinic. “Similar to many medical AI endeavors, developing a proof-of-concept or research prototype is far easier and faster than bringing the development to real users,” Dr. Liu said. “In particular, it is important to conduct thorough validation studies on various patient populations and settings and understand how these AI tools can best fit into the workflow or patient journey.”
A study published in 2023 documented progress Google made in deploying AI models in retina specialty clinics in India and Thailand, Dr. Liu noted.
Another challenge is to avoid overdiagnosis with these new technologies, Dr. Hartman said. Her group’s study showed the DermaSensor had a positive predictive value of 16% and a negative predictive value of 98.5%. “I think there’s some question about how this will factor into overdiagnosis. Could this actually bombard dermatologists more if the positive predictive value’s only 16%?”
One key to dermatologists accepting AI tools is having a transparent process for validating them, Dr. Lee said. “Even with FDA clearance, we don’t have the transparency we need as clinicians, researchers, and advocates of machine learning and AI in healthcare.”
But, Dr. Lee noted, the FDA in June took a step toward illuminating its validation process when it adopted guiding principles for transparency for machine learning–enabled devices. “Once we can get more access to this information and have more transparency, that’s where we can think about actually about making the decision to implement or not implement into local healthcare settings,” she said. The process was further enabled by a White House executive order in October 2023 on the safe, secure, and trustworthy development and use of AI.
The experience with telehealth during the COVID-19 pandemic, when patients and providers quickly embraced the technology to stay connected, serves as a potential template for AI, Dr. Lee noted. “As we’d seen with telehealth through the pandemic, you also need the cultural evolution and the development of the infrastructure around it to actually make sure this is a sustainable implementation and a scalable implementation in healthcare.”
Dr. Lee had no relevant relationships to disclose. Dr. Hartman received funding from DermaSensor for a study. Dr. Witkowski is a cofounder of Sklip. Dr. Liu is an employee of Google Research. Dr. Daneshjou reported financial relationships with MD Algorithms, Revea, and L’Oreal.
A version of this article first appeared on Medscape.com.
Emerging according to researchers and dermatologists investigating AI.
While some AI-integrated devices designed to triage skin lesions have emerged, including one that received Food and Drug Administration (FDA) clearance earlier in 2024, it may be some time before AI has a meaningful clinical impact in dermatology and, more specifically, the diagnosis of skin cancer, Ivy Lee, MD, a dermatologist in Pasadena, California, and chair of the American Academy of Dermatology’s augmented intelligence committee, told this news organization.
“It hasn’t really translated into clinical practice yet,” Dr. Lee said of AI in dermatology. “There have been significant advances in terms of the technical possibility and feasibility of these tools, but the translation and integration of AI into actual clinical work flows to benefit patients beyond academic research studies has been limited.” More studies and more “easily accessible and digestible information” are needed to evaluate AI tools in dermatologic practice.
“In dermatology, we’re on a cusp with AI,” said Rebecca Hartman, MD, MPH, chief of dermatology at the VA Boston Healthcare System and director of melanoma epidemiology at Brigham and Women’s Hospital, Boston, Massachusetts. “I think it’s going to come and change what we do,” which is especially true for any image-based specialty,” including radiology and pathology, in addition to dermatology.
Dr. Hartman led a study of one of these emerging technologies, the handheld elastic scattering spectroscopy device DermaSensor, which was cleared by the FDA in January for evaluating skin lesions suggestive of skin cancer.
Early AI Devices for Skin Cancer Detection
At the American Society for Laser Medicine and Surgery (ASLMS) meeting in April, a panel explored a number of algorithms with dermatologic applications that use AI to triage skin lesions, including DermaSensor.
Raman spectroscopy, which contains a handheld Raman probe, a diode laser, and a detecting spectrograph. A laser beam — which at 1.56 W/cm2 is below the maximum permissible exposure — focuses on the skin target with a 3.5-mm spot, gathers data on the target, and feeds it back into the unit that houses the algorithm that evaluates the spot analysis. It’s still in the investigative phase. A clinical trial, published almost 5 years ago, demonstrated a sensitivity of 90%-99% and a specificity of 24%-66% for skin cancer.
A dermatoscope called Sklip clips onto a smartphone and performs what company cofounder Alexander Witkowski, MD, PhD, described as an “optical painless virtual biopsy” for at-home use. The device uploads the captured image to an AI platform for analysis. It received FDA breakthrough device designation in 2022. At the ASLMS meeting, Dr. Witkowski said that clinical performance showed the device had a 97% sensitivity and 30% specificity for skin cancer.
DermaSensor, described in the study conducted by Dr. Hartman and others as a noninvasive, point-and-click spectrometer, is a wireless handheld piece that weighs about 10 ounces. The unit captures five recordings to generate a spectral reading, which an algorithm in the software unit analyzes. The study found a sensitivity of 95.5% and specificity of 32.5% for melanoma detection with the device.
The target market for DermaSensor is primary care physicians, and, according to the FDA announcement in January, it is indicated for evaluating skin lesions “suggestive” of melanoma, basal cell carcinoma (BCC), and/or squamous cell carcinoma (SCC) in patients aged 40 and older to “assist healthcare providers in determining whether to refer a patient to a dermatologist.”
So Many Cases, So Few Dermatologists
In dermatology, AI devices have the potential to streamline the crushing burden of diagnosing skin cancer, said Yun Liu, PhD, a senior staff scientist at Google Research, Mountain View, California, who’s worked on developing machine-learning tools in dermatology among other medical fields. “Many people cannot access dermatology expertise when they most need it, ie, without waiting a long time. This causes substantial morbidity for patients,” Dr. Liu said in an interview.
His own research of an AI-based tool to help primary care physicians and nurse practitioners in teledermatology practices diagnose skin conditions documented the shortage of dermatologists to triage lesions, including a finding that only about one quarter of skin conditions are seen by a specialist and that nonspecialists play a pivotal role in the management of skin lesions.
The Centers for Disease Control and Prevention reports that about 6.1 million adults are treated for BCC and SCCs each year. The American Medical Association estimates that 13,200 active dermatologists practice in the United States.
Overcoming Barriers to AI in Dermatology
Before AI makes significant inroads in dermatology, clinicians need to see more verifiable data, said Roxana Daneshjou, MD, PhD, assistant professor of biomedical data science and dermatology at Stanford University, Stanford, California. “One of the challenges is having the availability of models that actually improve clinical care because we have some very early prospective trials on different devices, but we don’t have large-scale randomized clinical trials of AI devices showing definitive behaviors such as improved patient outcomes, that it helps curb skin cancer, or it catches it like dermatologists but helps reduce the biopsy load,” she said. “You need good data.”
Another challenge she noted was overcoming biases built into medicine. “A lot of the image-based models are built on datasets depicting skin disease on White skin, and those models don’t work so well on people with brown and black skin, who have historically had worse outcomes and also have been underrepresented in dermatology,” said Dr. Daneshjou, an associate editor of NEJM AI.
There’s also the challenge of getting verified AI models into the clinic. “Similar to many medical AI endeavors, developing a proof-of-concept or research prototype is far easier and faster than bringing the development to real users,” Dr. Liu said. “In particular, it is important to conduct thorough validation studies on various patient populations and settings and understand how these AI tools can best fit into the workflow or patient journey.”
A study published in 2023 documented progress Google made in deploying AI models in retina specialty clinics in India and Thailand, Dr. Liu noted.
Another challenge is to avoid overdiagnosis with these new technologies, Dr. Hartman said. Her group’s study showed the DermaSensor had a positive predictive value of 16% and a negative predictive value of 98.5%. “I think there’s some question about how this will factor into overdiagnosis. Could this actually bombard dermatologists more if the positive predictive value’s only 16%?”
One key to dermatologists accepting AI tools is having a transparent process for validating them, Dr. Lee said. “Even with FDA clearance, we don’t have the transparency we need as clinicians, researchers, and advocates of machine learning and AI in healthcare.”
But, Dr. Lee noted, the FDA in June took a step toward illuminating its validation process when it adopted guiding principles for transparency for machine learning–enabled devices. “Once we can get more access to this information and have more transparency, that’s where we can think about actually about making the decision to implement or not implement into local healthcare settings,” she said. The process was further enabled by a White House executive order in October 2023 on the safe, secure, and trustworthy development and use of AI.
The experience with telehealth during the COVID-19 pandemic, when patients and providers quickly embraced the technology to stay connected, serves as a potential template for AI, Dr. Lee noted. “As we’d seen with telehealth through the pandemic, you also need the cultural evolution and the development of the infrastructure around it to actually make sure this is a sustainable implementation and a scalable implementation in healthcare.”
Dr. Lee had no relevant relationships to disclose. Dr. Hartman received funding from DermaSensor for a study. Dr. Witkowski is a cofounder of Sklip. Dr. Liu is an employee of Google Research. Dr. Daneshjou reported financial relationships with MD Algorithms, Revea, and L’Oreal.
A version of this article first appeared on Medscape.com.
Primary Care: Re Carpe Your Diem
William Fox, MD, a self-described “dinosaur,” works in an independent internal medicine practice with two other physicians in Charlottesville, Virginia. He is rarely able to accept new patients, and when he does see one, they often have to wait months for the appointment. He accepts the burden of many pent-up needs, along with the huge administrative chore of coordinating their care with subspecialists.
“I will probably have to make multiple visits in a quick succession in order to make sure that I stabilize all the various issues,” Dr. Fox said. Doing so for a complicated new patient is nearly impossible because of time pressures, especially as it has become increasingly difficult for his patients to access subspecialists.
Dr. Fox traced the roots of the problem to a shortage of primary care physicians.
“Primary care is a vital part of healthcare and infrastructure in the United States, and it is being eroded unfortunately, as fewer and fewer medical students and residents choose to go into the primary care field,” Fox said. “And the reason it’s being eroded partly is because it is undervalued” and under-reimbursed, he added.
A study published 2 years ago in the Journal of General Internal Medicine proved what every primary care clinician already knows: The 24-hour day simply isn’t long enough.
Assuming an average panel of 2500 patients, the authors estimated the average time needed to provide currently recommended preventive care services and vaccines, chronic disease care, and management of acute illnesses. The answer: 26.7 hours a day.
However, using a team-based approach in which the necessary care was divided between physicians, advanced practice providers, and medical assistants, the physician component could be whittled down to 9 hours.
As chair of the Board of Regents of the American College of Physicians (ACP), Dr. Fox champions the ACP’s endorsement of physician-led team-based care, which improves patient outcomes and increases well-being among health professionals. But practices like his rarely have the necessary resources to support advanced practice clinicians or social workers. “Team-based care can be achieved in larger healthcare systems that have the resources to do it,” said Dr. Fox. “We need to find a way for smaller independent practices to also participate in team-based care.”
The solution? Major reform in the current fee-for-service payment structure, which incentivizes patient volume over patient outcomes. Dr. Fox co-authored a 2022 position statement from ACP outlining strategies such as prospective payment models that could achieve high-quality care and address social inequities. “We need to evolve our payment system from a fee-for-service system into a blended system where you have some population-based payments along with fee-for-service, or a fully capitated system,” he said.
Advantages of Team-Based Care
When a patient wrote on a satisfaction survey “the doctor spent more time examining the computer than examining me,” Kevin Hopkins, MD, decided he needed to change some things. Now the vice chief of Cleveland Clinic’s Primary Care Institute in Cleveland, in 2010, he developed a rudimentary team-based care model consisting of himself and two medical assistants at Cleveland Clinic.
The assistants did much of the patient intake, served as scribes while Dr. Hopkins saw his patients, and completed most of the required documentation. “I was able to see 30% more patients in a day and still take great care of them,” Dr. Hopkins said.
The concept of team-based care has evolved since then, often including some combination of advanced practice providers such as physician assistants (PAs) or nurse practitioners (NPs), nurses or medical assistants, and social workers or case managers working under the leadership of a physician. According to Dr. Hopkins, the basic strategy should be that “the physician does what only the physician is uniquely trained and qualified to do.” All other tasks, such as data entry, handling refill requests and messages from the patient portal, scheduling, or patient education, can — and should — be done by someone else.
Dr. Hopkins also serves as a senior physician advisor to the American Medical Association (AMA) and an instructor for workshops like “Saving Time: Practice Innovation Boot Camp.” His advice for clinicians who would like to streamline their workflow is to start with small steps.
“You’re not going to be able to hire all the people that you’d like to have,” he said. “I encourage physicians to look around at the people that they have and what they are currently doing as a part of their roles and responsibilities.”
The AMA Team-Based Care and Workflow website provides brief continuing medical education activities on topics such as implementing lab testing prior to office visits or advanced protocols for rooming and discharge; adopting any of these strategies can help save steps during office visits.
Dr. Hopkins said the AMA is committed to reducing the regulatory burden on clinicians. Clinical compliance officers may misinterpret regulatory requirements, putting into place overly conservative internal policies and procedures. The AMA’s “Reducing Regulatory Burden Playbook” offers advice on practices that could be stopped, such as two-factor authentication for approving or signing orders unless they are for controlled substances, or started, such as writing prescriptions for chronic daily medications for the maximum allowed length. Reducing a few clicks with each log-on to the electronic health record or reducing the number of tasks physicians must complete to log on can dramatically reduce hours spent on the computer.
Telehealth Changes Everything
But it might be even more efficient to keep patients out of the office.
Initially piloted in Palo Alto, California, from 2018 to 2022, the Tera Practice adopted team-based care strategies in a practice that conducts most of its work virtually. Sutter Health has since expanded the concept to three “Connected Care Clinics” in the San Francisco area, which provide 80% of their care via secure messaging, telephone, or video visit. Staff work primarily from home, and patients do not need to take off work or spend time driving to in-person visits to access care.
Matthew Sakumoto, MD, is a virtualist primary care physician at Sutter Health’s San Francisco clinic and an adjunct assistant clinical professor at the University of California, San Francisco. He leads a three-person team, which typically has included either an NP or a PA, along with a licensed vocational nurse or medical assistant.
“I go into clinic once a week, but a lot of the visits are video visits, so I don’t feel the pressure to address everything all in one visit,” Dr. Sakumoto said. “It is really freeing for both me and the patient.”
For more complex patients, for example, he prioritizes one problem at a visit because his team will follow up virtually for administrative issues like refills or specialty referrals. He can easily find time to schedule a patient for a follow-up virtual visit in the next week or 2 weeks to address additional needs. And on days he and his staff work from home, patients who message with an urgent concern can often be seen by video that same day.
Dr. Sakumoto and his team have a traditional huddle in the office the morning of their clinic day to plan for the scheduled visits, but most of their days are less structured. On non-clinic days, their morning Zoom huddle has a much different focus.
“We’re saying, ‘Okay, who are our high-risk patients? Who haven’t we seen in a while?’ ” Dr. Sakumoto said. They group patients into tiers based on factors such as age, number of complex medical needs, and frequency of emergency visits or hospitalizations. They also check in with higher-risk patients who haven’t contacted the office or been seen recently.
Dr. Sakumoto noticed in medical school doctors take excellent care of the patients who show up to the clinic. “We don’t do quite as well for those that don’t show up,” he said. The hybrid-virtual model gives him time to think in a more population-based way about engaging his entire panel of patients. The majority have capitated or value-based insurance plans, providing a dedicated monthly revenue stream that funds his virtual practice.
More clinicians may be able to hire staff and adopt some of these innovative approaches if Congress approves proposed changes to Medicare and Medicaid increasing the use of value-based payment systems. Although these changes may not provide all the funding needed to reinvigorate the field of primary care medicine, Dr. Fox said, “at least some people in positions of power and responsibility are beginning to think more seriously about these issues.”
Dr. Sakumoto reported personal fees from the following companies within the past 24 months: Clearstep Health, Carbon Health, Matter Health, CareAlign, PlushCare, Teladoc, and Nabla Health. Dr. Fox and Dr. Hopkins reported no financial conflicts of interest.
A former pediatrician and disease detective, Ann Thomas, MD, MPH, is a freelance science writer living in Portland, Oregon.
A version of this article first appeared on Medscape.com.
William Fox, MD, a self-described “dinosaur,” works in an independent internal medicine practice with two other physicians in Charlottesville, Virginia. He is rarely able to accept new patients, and when he does see one, they often have to wait months for the appointment. He accepts the burden of many pent-up needs, along with the huge administrative chore of coordinating their care with subspecialists.
“I will probably have to make multiple visits in a quick succession in order to make sure that I stabilize all the various issues,” Dr. Fox said. Doing so for a complicated new patient is nearly impossible because of time pressures, especially as it has become increasingly difficult for his patients to access subspecialists.
Dr. Fox traced the roots of the problem to a shortage of primary care physicians.
“Primary care is a vital part of healthcare and infrastructure in the United States, and it is being eroded unfortunately, as fewer and fewer medical students and residents choose to go into the primary care field,” Fox said. “And the reason it’s being eroded partly is because it is undervalued” and under-reimbursed, he added.
A study published 2 years ago in the Journal of General Internal Medicine proved what every primary care clinician already knows: The 24-hour day simply isn’t long enough.
Assuming an average panel of 2500 patients, the authors estimated the average time needed to provide currently recommended preventive care services and vaccines, chronic disease care, and management of acute illnesses. The answer: 26.7 hours a day.
However, using a team-based approach in which the necessary care was divided between physicians, advanced practice providers, and medical assistants, the physician component could be whittled down to 9 hours.
As chair of the Board of Regents of the American College of Physicians (ACP), Dr. Fox champions the ACP’s endorsement of physician-led team-based care, which improves patient outcomes and increases well-being among health professionals. But practices like his rarely have the necessary resources to support advanced practice clinicians or social workers. “Team-based care can be achieved in larger healthcare systems that have the resources to do it,” said Dr. Fox. “We need to find a way for smaller independent practices to also participate in team-based care.”
The solution? Major reform in the current fee-for-service payment structure, which incentivizes patient volume over patient outcomes. Dr. Fox co-authored a 2022 position statement from ACP outlining strategies such as prospective payment models that could achieve high-quality care and address social inequities. “We need to evolve our payment system from a fee-for-service system into a blended system where you have some population-based payments along with fee-for-service, or a fully capitated system,” he said.
Advantages of Team-Based Care
When a patient wrote on a satisfaction survey “the doctor spent more time examining the computer than examining me,” Kevin Hopkins, MD, decided he needed to change some things. Now the vice chief of Cleveland Clinic’s Primary Care Institute in Cleveland, in 2010, he developed a rudimentary team-based care model consisting of himself and two medical assistants at Cleveland Clinic.
The assistants did much of the patient intake, served as scribes while Dr. Hopkins saw his patients, and completed most of the required documentation. “I was able to see 30% more patients in a day and still take great care of them,” Dr. Hopkins said.
The concept of team-based care has evolved since then, often including some combination of advanced practice providers such as physician assistants (PAs) or nurse practitioners (NPs), nurses or medical assistants, and social workers or case managers working under the leadership of a physician. According to Dr. Hopkins, the basic strategy should be that “the physician does what only the physician is uniquely trained and qualified to do.” All other tasks, such as data entry, handling refill requests and messages from the patient portal, scheduling, or patient education, can — and should — be done by someone else.
Dr. Hopkins also serves as a senior physician advisor to the American Medical Association (AMA) and an instructor for workshops like “Saving Time: Practice Innovation Boot Camp.” His advice for clinicians who would like to streamline their workflow is to start with small steps.
“You’re not going to be able to hire all the people that you’d like to have,” he said. “I encourage physicians to look around at the people that they have and what they are currently doing as a part of their roles and responsibilities.”
The AMA Team-Based Care and Workflow website provides brief continuing medical education activities on topics such as implementing lab testing prior to office visits or advanced protocols for rooming and discharge; adopting any of these strategies can help save steps during office visits.
Dr. Hopkins said the AMA is committed to reducing the regulatory burden on clinicians. Clinical compliance officers may misinterpret regulatory requirements, putting into place overly conservative internal policies and procedures. The AMA’s “Reducing Regulatory Burden Playbook” offers advice on practices that could be stopped, such as two-factor authentication for approving or signing orders unless they are for controlled substances, or started, such as writing prescriptions for chronic daily medications for the maximum allowed length. Reducing a few clicks with each log-on to the electronic health record or reducing the number of tasks physicians must complete to log on can dramatically reduce hours spent on the computer.
Telehealth Changes Everything
But it might be even more efficient to keep patients out of the office.
Initially piloted in Palo Alto, California, from 2018 to 2022, the Tera Practice adopted team-based care strategies in a practice that conducts most of its work virtually. Sutter Health has since expanded the concept to three “Connected Care Clinics” in the San Francisco area, which provide 80% of their care via secure messaging, telephone, or video visit. Staff work primarily from home, and patients do not need to take off work or spend time driving to in-person visits to access care.
Matthew Sakumoto, MD, is a virtualist primary care physician at Sutter Health’s San Francisco clinic and an adjunct assistant clinical professor at the University of California, San Francisco. He leads a three-person team, which typically has included either an NP or a PA, along with a licensed vocational nurse or medical assistant.
“I go into clinic once a week, but a lot of the visits are video visits, so I don’t feel the pressure to address everything all in one visit,” Dr. Sakumoto said. “It is really freeing for both me and the patient.”
For more complex patients, for example, he prioritizes one problem at a visit because his team will follow up virtually for administrative issues like refills or specialty referrals. He can easily find time to schedule a patient for a follow-up virtual visit in the next week or 2 weeks to address additional needs. And on days he and his staff work from home, patients who message with an urgent concern can often be seen by video that same day.
Dr. Sakumoto and his team have a traditional huddle in the office the morning of their clinic day to plan for the scheduled visits, but most of their days are less structured. On non-clinic days, their morning Zoom huddle has a much different focus.
“We’re saying, ‘Okay, who are our high-risk patients? Who haven’t we seen in a while?’ ” Dr. Sakumoto said. They group patients into tiers based on factors such as age, number of complex medical needs, and frequency of emergency visits or hospitalizations. They also check in with higher-risk patients who haven’t contacted the office or been seen recently.
Dr. Sakumoto noticed in medical school doctors take excellent care of the patients who show up to the clinic. “We don’t do quite as well for those that don’t show up,” he said. The hybrid-virtual model gives him time to think in a more population-based way about engaging his entire panel of patients. The majority have capitated or value-based insurance plans, providing a dedicated monthly revenue stream that funds his virtual practice.
More clinicians may be able to hire staff and adopt some of these innovative approaches if Congress approves proposed changes to Medicare and Medicaid increasing the use of value-based payment systems. Although these changes may not provide all the funding needed to reinvigorate the field of primary care medicine, Dr. Fox said, “at least some people in positions of power and responsibility are beginning to think more seriously about these issues.”
Dr. Sakumoto reported personal fees from the following companies within the past 24 months: Clearstep Health, Carbon Health, Matter Health, CareAlign, PlushCare, Teladoc, and Nabla Health. Dr. Fox and Dr. Hopkins reported no financial conflicts of interest.
A former pediatrician and disease detective, Ann Thomas, MD, MPH, is a freelance science writer living in Portland, Oregon.
A version of this article first appeared on Medscape.com.
William Fox, MD, a self-described “dinosaur,” works in an independent internal medicine practice with two other physicians in Charlottesville, Virginia. He is rarely able to accept new patients, and when he does see one, they often have to wait months for the appointment. He accepts the burden of many pent-up needs, along with the huge administrative chore of coordinating their care with subspecialists.
“I will probably have to make multiple visits in a quick succession in order to make sure that I stabilize all the various issues,” Dr. Fox said. Doing so for a complicated new patient is nearly impossible because of time pressures, especially as it has become increasingly difficult for his patients to access subspecialists.
Dr. Fox traced the roots of the problem to a shortage of primary care physicians.
“Primary care is a vital part of healthcare and infrastructure in the United States, and it is being eroded unfortunately, as fewer and fewer medical students and residents choose to go into the primary care field,” Fox said. “And the reason it’s being eroded partly is because it is undervalued” and under-reimbursed, he added.
A study published 2 years ago in the Journal of General Internal Medicine proved what every primary care clinician already knows: The 24-hour day simply isn’t long enough.
Assuming an average panel of 2500 patients, the authors estimated the average time needed to provide currently recommended preventive care services and vaccines, chronic disease care, and management of acute illnesses. The answer: 26.7 hours a day.
However, using a team-based approach in which the necessary care was divided between physicians, advanced practice providers, and medical assistants, the physician component could be whittled down to 9 hours.
As chair of the Board of Regents of the American College of Physicians (ACP), Dr. Fox champions the ACP’s endorsement of physician-led team-based care, which improves patient outcomes and increases well-being among health professionals. But practices like his rarely have the necessary resources to support advanced practice clinicians or social workers. “Team-based care can be achieved in larger healthcare systems that have the resources to do it,” said Dr. Fox. “We need to find a way for smaller independent practices to also participate in team-based care.”
The solution? Major reform in the current fee-for-service payment structure, which incentivizes patient volume over patient outcomes. Dr. Fox co-authored a 2022 position statement from ACP outlining strategies such as prospective payment models that could achieve high-quality care and address social inequities. “We need to evolve our payment system from a fee-for-service system into a blended system where you have some population-based payments along with fee-for-service, or a fully capitated system,” he said.
Advantages of Team-Based Care
When a patient wrote on a satisfaction survey “the doctor spent more time examining the computer than examining me,” Kevin Hopkins, MD, decided he needed to change some things. Now the vice chief of Cleveland Clinic’s Primary Care Institute in Cleveland, in 2010, he developed a rudimentary team-based care model consisting of himself and two medical assistants at Cleveland Clinic.
The assistants did much of the patient intake, served as scribes while Dr. Hopkins saw his patients, and completed most of the required documentation. “I was able to see 30% more patients in a day and still take great care of them,” Dr. Hopkins said.
The concept of team-based care has evolved since then, often including some combination of advanced practice providers such as physician assistants (PAs) or nurse practitioners (NPs), nurses or medical assistants, and social workers or case managers working under the leadership of a physician. According to Dr. Hopkins, the basic strategy should be that “the physician does what only the physician is uniquely trained and qualified to do.” All other tasks, such as data entry, handling refill requests and messages from the patient portal, scheduling, or patient education, can — and should — be done by someone else.
Dr. Hopkins also serves as a senior physician advisor to the American Medical Association (AMA) and an instructor for workshops like “Saving Time: Practice Innovation Boot Camp.” His advice for clinicians who would like to streamline their workflow is to start with small steps.
“You’re not going to be able to hire all the people that you’d like to have,” he said. “I encourage physicians to look around at the people that they have and what they are currently doing as a part of their roles and responsibilities.”
The AMA Team-Based Care and Workflow website provides brief continuing medical education activities on topics such as implementing lab testing prior to office visits or advanced protocols for rooming and discharge; adopting any of these strategies can help save steps during office visits.
Dr. Hopkins said the AMA is committed to reducing the regulatory burden on clinicians. Clinical compliance officers may misinterpret regulatory requirements, putting into place overly conservative internal policies and procedures. The AMA’s “Reducing Regulatory Burden Playbook” offers advice on practices that could be stopped, such as two-factor authentication for approving or signing orders unless they are for controlled substances, or started, such as writing prescriptions for chronic daily medications for the maximum allowed length. Reducing a few clicks with each log-on to the electronic health record or reducing the number of tasks physicians must complete to log on can dramatically reduce hours spent on the computer.
Telehealth Changes Everything
But it might be even more efficient to keep patients out of the office.
Initially piloted in Palo Alto, California, from 2018 to 2022, the Tera Practice adopted team-based care strategies in a practice that conducts most of its work virtually. Sutter Health has since expanded the concept to three “Connected Care Clinics” in the San Francisco area, which provide 80% of their care via secure messaging, telephone, or video visit. Staff work primarily from home, and patients do not need to take off work or spend time driving to in-person visits to access care.
Matthew Sakumoto, MD, is a virtualist primary care physician at Sutter Health’s San Francisco clinic and an adjunct assistant clinical professor at the University of California, San Francisco. He leads a three-person team, which typically has included either an NP or a PA, along with a licensed vocational nurse or medical assistant.
“I go into clinic once a week, but a lot of the visits are video visits, so I don’t feel the pressure to address everything all in one visit,” Dr. Sakumoto said. “It is really freeing for both me and the patient.”
For more complex patients, for example, he prioritizes one problem at a visit because his team will follow up virtually for administrative issues like refills or specialty referrals. He can easily find time to schedule a patient for a follow-up virtual visit in the next week or 2 weeks to address additional needs. And on days he and his staff work from home, patients who message with an urgent concern can often be seen by video that same day.
Dr. Sakumoto and his team have a traditional huddle in the office the morning of their clinic day to plan for the scheduled visits, but most of their days are less structured. On non-clinic days, their morning Zoom huddle has a much different focus.
“We’re saying, ‘Okay, who are our high-risk patients? Who haven’t we seen in a while?’ ” Dr. Sakumoto said. They group patients into tiers based on factors such as age, number of complex medical needs, and frequency of emergency visits or hospitalizations. They also check in with higher-risk patients who haven’t contacted the office or been seen recently.
Dr. Sakumoto noticed in medical school doctors take excellent care of the patients who show up to the clinic. “We don’t do quite as well for those that don’t show up,” he said. The hybrid-virtual model gives him time to think in a more population-based way about engaging his entire panel of patients. The majority have capitated or value-based insurance plans, providing a dedicated monthly revenue stream that funds his virtual practice.
More clinicians may be able to hire staff and adopt some of these innovative approaches if Congress approves proposed changes to Medicare and Medicaid increasing the use of value-based payment systems. Although these changes may not provide all the funding needed to reinvigorate the field of primary care medicine, Dr. Fox said, “at least some people in positions of power and responsibility are beginning to think more seriously about these issues.”
Dr. Sakumoto reported personal fees from the following companies within the past 24 months: Clearstep Health, Carbon Health, Matter Health, CareAlign, PlushCare, Teladoc, and Nabla Health. Dr. Fox and Dr. Hopkins reported no financial conflicts of interest.
A former pediatrician and disease detective, Ann Thomas, MD, MPH, is a freelance science writer living in Portland, Oregon.
A version of this article first appeared on Medscape.com.
Rural Women Face Greater Challenges in Perimenopause
Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.
Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”
The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).
This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.
Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.
In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.
“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
Rural Physicians’ Role
Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.
Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.
According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.
Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.
An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.
Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
Call for Training
Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.
“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.
Dr. Llaneza declared that she has no relevant financial relationships.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.
Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”
The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).
This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.
Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.
In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.
“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
Rural Physicians’ Role
Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.
Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.
According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.
Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.
An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.
Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
Call for Training
Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.
“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.
Dr. Llaneza declared that she has no relevant financial relationships.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.
Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”
The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).
This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.
Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.
In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.
“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
Rural Physicians’ Role
Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.
Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.
According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.
Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.
An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.
Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
Call for Training
Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.
“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.
Dr. Llaneza declared that she has no relevant financial relationships.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Is Vision Loss a New Dementia Risk Factor? What Do the Data Say?
In 2019, 57 million people worldwide were living with dementia, a figure expected to soar to 153 million by 2050. A recent Lancet Commission report suggests that nearly half of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors, including impaired vision.
The report’s authors recommend that vision-loss screening and treatment be universally available. But are these recommendations warranted? What is the evidence? What is the potential mechanism? And what are the potential implications for clinical practice?
Worldwide, the prevalence of avoidable vision loss and blindness in adults aged 50 years or older is estimated to hover around 13%.
“There is now overwhelming evidence that vision impairment in later life is associated with more rapid cognitive decline and an increased risk of dementia,” said Joshua Ehrlich, MD, MPH, associate professor in ophthalmology and visual sciences, the Institute for Social Research at the University of Michigan, Ann Arbor.
The evidence includes a meta-analysis of 14 prospective cohort studies with roughly 6.2 million older adults who were cognitively intact at baseline. Over the course of up to 14 years, 171,888 developed dementia. Vision loss was associated with a pooled relative risk (RR) for dementia of 1.47.
A separate meta-analysis also identified an increased risk for dementia (RR, 1.38) with visual loss. When broken down into different eye conditions, an increased dementia risk was associated with cataracts and diabetic retinopathy but not with glaucoma or age-related macular degeneration.
A US study that followed roughly 3000 older adults with cataracts and normal cognition at baseline for more than 20 years found that those who had cataract extraction had significantly reduced risk for dementia compared with those who did not have cataract extraction (hazard ratio, 0.71), after controlling for age, race, APOE genotype, education, smoking, and an extensive list of comorbidities.
Causation or Coincidence?
The mechanisms behind these associations might be related to underlying illness, such as diabetes, which is a risk factor for dementia; vision loss itself, as might be suggested by a possible effect of cataract surgery; or shared neuropathologic processes in the retina and the brain.
A longitudinal study from Korea that included roughly 6 million adults showed that dementia risk increased with severity of visual loss, which supports the hypothesis that vision loss in itself might be causal or that there is a dose-response effect to a shared causal factor.
“Work is still needed to sort out” exactly how visual deficits may raise dementia risk, although several hypotheses exist, Dr. Ehrlich said.
For example, “decreased input to the brain via the visual pathways may directly induce brain changes. Also, consequences of vision loss, like social isolation, physical inactivity, and depression, are themselves risk factors for dementia and may explain the pathways through which vision impairment increases risk,” he said.
Is the link causal? “We’ll never know definitively because we can’t randomize people to not get cataract surgery versus getting cataract surgery, because we know that improving vision improves quality of life, so we’d never want to do that. But the new evidence that’s come in over the last 5 years or so is pretty promising,” said Esme Fuller-Thomson, PhD, director of the Institute for Life Course and Aging and professor, Department of Family and Community Medicine and Faculty of Nursing, at the University of Toronto, Ontario, Canada.
She noted that results of two studies that have looked at this “seem to indicate that those who have cataract surgery are not nearly at as high risk of dementia as those who have cataracts but don’t have the surgery. That’s leaning towards causality.”
A study published in July suggests that cataracts increase dementia risk through vascular and non–Alzheimer’s disease mechanisms.
Clear Clinical Implications
Dr. Ehrlich said that evidence for an association between untreated vision loss and dementia risk and potential modification by treatment has clear implications for care.
“Loss of vision impacts so many aspects of people’s lives beyond just how they see the world and losing vision in later life is not a normal part of aging. Thus, when older adults experience vision loss, this should be a cause for concern and prompt an immediate referral to an eye care professional,” he noted.
Dr. Fuller-Thomson agrees. “Addressing vision loss will certainly help people see better and function at a higher level and improve quality of life, and it seems probable that it might decrease dementia risk so it’s a win-win,” she said.
In her own research, Dr. Fuller-Thomson has found that the combination of hearing loss and vision loss is linked to an eightfold increased risk for cognitive impairment.
“The idea is that vision and/or hearing loss makes it harder for you to be physically active, to be socially engaged, to be mentally stimulated. They are equally important in terms of social isolation, which could lead to loneliness, and we know that loneliness is not good for dementia,” she said.
“With dual sensory impairment, you don’t have as much information coming in — your brain is not engaged as much — and having an engaged brain, doing hobbies, having intellectually stimulating conversation, all of those are factors are associated with lowering risk of dementia,” Dr. Fuller-Thomson said.
The latest Lancet Commission report noted that treatment for visual loss is “effective and cost-effective” for an estimated 90% of people. However, across the world, particularly in low- and middle-income countries, visual loss often goes untreated.
the report concluded.
Dr. Ehrlich and Dr. Fuller-Thomson have no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
In 2019, 57 million people worldwide were living with dementia, a figure expected to soar to 153 million by 2050. A recent Lancet Commission report suggests that nearly half of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors, including impaired vision.
The report’s authors recommend that vision-loss screening and treatment be universally available. But are these recommendations warranted? What is the evidence? What is the potential mechanism? And what are the potential implications for clinical practice?
Worldwide, the prevalence of avoidable vision loss and blindness in adults aged 50 years or older is estimated to hover around 13%.
“There is now overwhelming evidence that vision impairment in later life is associated with more rapid cognitive decline and an increased risk of dementia,” said Joshua Ehrlich, MD, MPH, associate professor in ophthalmology and visual sciences, the Institute for Social Research at the University of Michigan, Ann Arbor.
The evidence includes a meta-analysis of 14 prospective cohort studies with roughly 6.2 million older adults who were cognitively intact at baseline. Over the course of up to 14 years, 171,888 developed dementia. Vision loss was associated with a pooled relative risk (RR) for dementia of 1.47.
A separate meta-analysis also identified an increased risk for dementia (RR, 1.38) with visual loss. When broken down into different eye conditions, an increased dementia risk was associated with cataracts and diabetic retinopathy but not with glaucoma or age-related macular degeneration.
A US study that followed roughly 3000 older adults with cataracts and normal cognition at baseline for more than 20 years found that those who had cataract extraction had significantly reduced risk for dementia compared with those who did not have cataract extraction (hazard ratio, 0.71), after controlling for age, race, APOE genotype, education, smoking, and an extensive list of comorbidities.
Causation or Coincidence?
The mechanisms behind these associations might be related to underlying illness, such as diabetes, which is a risk factor for dementia; vision loss itself, as might be suggested by a possible effect of cataract surgery; or shared neuropathologic processes in the retina and the brain.
A longitudinal study from Korea that included roughly 6 million adults showed that dementia risk increased with severity of visual loss, which supports the hypothesis that vision loss in itself might be causal or that there is a dose-response effect to a shared causal factor.
“Work is still needed to sort out” exactly how visual deficits may raise dementia risk, although several hypotheses exist, Dr. Ehrlich said.
For example, “decreased input to the brain via the visual pathways may directly induce brain changes. Also, consequences of vision loss, like social isolation, physical inactivity, and depression, are themselves risk factors for dementia and may explain the pathways through which vision impairment increases risk,” he said.
Is the link causal? “We’ll never know definitively because we can’t randomize people to not get cataract surgery versus getting cataract surgery, because we know that improving vision improves quality of life, so we’d never want to do that. But the new evidence that’s come in over the last 5 years or so is pretty promising,” said Esme Fuller-Thomson, PhD, director of the Institute for Life Course and Aging and professor, Department of Family and Community Medicine and Faculty of Nursing, at the University of Toronto, Ontario, Canada.
She noted that results of two studies that have looked at this “seem to indicate that those who have cataract surgery are not nearly at as high risk of dementia as those who have cataracts but don’t have the surgery. That’s leaning towards causality.”
A study published in July suggests that cataracts increase dementia risk through vascular and non–Alzheimer’s disease mechanisms.
Clear Clinical Implications
Dr. Ehrlich said that evidence for an association between untreated vision loss and dementia risk and potential modification by treatment has clear implications for care.
“Loss of vision impacts so many aspects of people’s lives beyond just how they see the world and losing vision in later life is not a normal part of aging. Thus, when older adults experience vision loss, this should be a cause for concern and prompt an immediate referral to an eye care professional,” he noted.
Dr. Fuller-Thomson agrees. “Addressing vision loss will certainly help people see better and function at a higher level and improve quality of life, and it seems probable that it might decrease dementia risk so it’s a win-win,” she said.
In her own research, Dr. Fuller-Thomson has found that the combination of hearing loss and vision loss is linked to an eightfold increased risk for cognitive impairment.
“The idea is that vision and/or hearing loss makes it harder for you to be physically active, to be socially engaged, to be mentally stimulated. They are equally important in terms of social isolation, which could lead to loneliness, and we know that loneliness is not good for dementia,” she said.
“With dual sensory impairment, you don’t have as much information coming in — your brain is not engaged as much — and having an engaged brain, doing hobbies, having intellectually stimulating conversation, all of those are factors are associated with lowering risk of dementia,” Dr. Fuller-Thomson said.
The latest Lancet Commission report noted that treatment for visual loss is “effective and cost-effective” for an estimated 90% of people. However, across the world, particularly in low- and middle-income countries, visual loss often goes untreated.
the report concluded.
Dr. Ehrlich and Dr. Fuller-Thomson have no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
In 2019, 57 million people worldwide were living with dementia, a figure expected to soar to 153 million by 2050. A recent Lancet Commission report suggests that nearly half of dementia cases could be prevented or delayed by addressing 14 modifiable risk factors, including impaired vision.
The report’s authors recommend that vision-loss screening and treatment be universally available. But are these recommendations warranted? What is the evidence? What is the potential mechanism? And what are the potential implications for clinical practice?
Worldwide, the prevalence of avoidable vision loss and blindness in adults aged 50 years or older is estimated to hover around 13%.
“There is now overwhelming evidence that vision impairment in later life is associated with more rapid cognitive decline and an increased risk of dementia,” said Joshua Ehrlich, MD, MPH, associate professor in ophthalmology and visual sciences, the Institute for Social Research at the University of Michigan, Ann Arbor.
The evidence includes a meta-analysis of 14 prospective cohort studies with roughly 6.2 million older adults who were cognitively intact at baseline. Over the course of up to 14 years, 171,888 developed dementia. Vision loss was associated with a pooled relative risk (RR) for dementia of 1.47.
A separate meta-analysis also identified an increased risk for dementia (RR, 1.38) with visual loss. When broken down into different eye conditions, an increased dementia risk was associated with cataracts and diabetic retinopathy but not with glaucoma or age-related macular degeneration.
A US study that followed roughly 3000 older adults with cataracts and normal cognition at baseline for more than 20 years found that those who had cataract extraction had significantly reduced risk for dementia compared with those who did not have cataract extraction (hazard ratio, 0.71), after controlling for age, race, APOE genotype, education, smoking, and an extensive list of comorbidities.
Causation or Coincidence?
The mechanisms behind these associations might be related to underlying illness, such as diabetes, which is a risk factor for dementia; vision loss itself, as might be suggested by a possible effect of cataract surgery; or shared neuropathologic processes in the retina and the brain.
A longitudinal study from Korea that included roughly 6 million adults showed that dementia risk increased with severity of visual loss, which supports the hypothesis that vision loss in itself might be causal or that there is a dose-response effect to a shared causal factor.
“Work is still needed to sort out” exactly how visual deficits may raise dementia risk, although several hypotheses exist, Dr. Ehrlich said.
For example, “decreased input to the brain via the visual pathways may directly induce brain changes. Also, consequences of vision loss, like social isolation, physical inactivity, and depression, are themselves risk factors for dementia and may explain the pathways through which vision impairment increases risk,” he said.
Is the link causal? “We’ll never know definitively because we can’t randomize people to not get cataract surgery versus getting cataract surgery, because we know that improving vision improves quality of life, so we’d never want to do that. But the new evidence that’s come in over the last 5 years or so is pretty promising,” said Esme Fuller-Thomson, PhD, director of the Institute for Life Course and Aging and professor, Department of Family and Community Medicine and Faculty of Nursing, at the University of Toronto, Ontario, Canada.
She noted that results of two studies that have looked at this “seem to indicate that those who have cataract surgery are not nearly at as high risk of dementia as those who have cataracts but don’t have the surgery. That’s leaning towards causality.”
A study published in July suggests that cataracts increase dementia risk through vascular and non–Alzheimer’s disease mechanisms.
Clear Clinical Implications
Dr. Ehrlich said that evidence for an association between untreated vision loss and dementia risk and potential modification by treatment has clear implications for care.
“Loss of vision impacts so many aspects of people’s lives beyond just how they see the world and losing vision in later life is not a normal part of aging. Thus, when older adults experience vision loss, this should be a cause for concern and prompt an immediate referral to an eye care professional,” he noted.
Dr. Fuller-Thomson agrees. “Addressing vision loss will certainly help people see better and function at a higher level and improve quality of life, and it seems probable that it might decrease dementia risk so it’s a win-win,” she said.
In her own research, Dr. Fuller-Thomson has found that the combination of hearing loss and vision loss is linked to an eightfold increased risk for cognitive impairment.
“The idea is that vision and/or hearing loss makes it harder for you to be physically active, to be socially engaged, to be mentally stimulated. They are equally important in terms of social isolation, which could lead to loneliness, and we know that loneliness is not good for dementia,” she said.
“With dual sensory impairment, you don’t have as much information coming in — your brain is not engaged as much — and having an engaged brain, doing hobbies, having intellectually stimulating conversation, all of those are factors are associated with lowering risk of dementia,” Dr. Fuller-Thomson said.
The latest Lancet Commission report noted that treatment for visual loss is “effective and cost-effective” for an estimated 90% of people. However, across the world, particularly in low- and middle-income countries, visual loss often goes untreated.
the report concluded.
Dr. Ehrlich and Dr. Fuller-Thomson have no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
Doctors Are Seeking Professional Coaches More Often. Here’s Why
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
Is There a Role for GLP-1s in Neurology and Psychiatry?
This transcript has been edited for clarity.
I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.
I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.
These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.
The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.
We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism.
In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
Stroke, Smoking, and Alcohol
A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.
You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.
In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing.
Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.
A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.
There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing.
Parkinson’s Disease
Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease.
Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors.
A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.
The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy.
These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.
If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.
Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases.
Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.
I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.
These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.
The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.
We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism.
In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
Stroke, Smoking, and Alcohol
A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.
You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.
In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing.
Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.
A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.
There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing.
Parkinson’s Disease
Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease.
Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors.
A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.
The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy.
These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.
If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.
Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases.
Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I usually report five or six studies in the field of neurology that were published in the last months, but July was a vacation month.
I decided to cover another topic, which is the role of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists beyond diabetes and obesity, and in particular, for the field of neurology and psychiatry. Until a few years ago, the treatment of diabetes with traditional antidiabetic drugs was frustrating for vascular neurologists.
These drugs would lower glucose and had an impact on small-vessel disease, but they had no impact on large-vessel disease, stroke, and vascular mortality. This changed with the sodium-glucose cotransporter 2 antagonists because these drugs were not only effective for diabetes, but they also lowered cardiac mortality, in particular, in patients with cardiac failure.
The next generation of antidiabetic drugs were the GLP-1 receptor agonists and the combined GIP/GLP-1 receptor agonists. These two polypeptides and their receptors play a very important role in diabetes and in obesity. The receptors are found not only in the pancreas but also in the intestinal system, the liver, and the central nervous system.
We have a number of preclinical models, mostly in transgenic mice, which show that these drugs are not effective only in diabetes and obesity, but also in liver disease, kidney failure, and neurodegenerative diseases. GLP-1 receptor agonists also have powerful anti-inflammatory properties. These drugs reduce body weight, and they have positive effects on blood pressure and lipid metabolism.
In the studies on the use of GLP-1 receptor agonists in diabetes, a meta-analysis with more than 58,000 patients showed a significant risk reduction for stroke compared with placebo, and this risk reduction was in the range of 80%.
Stroke, Smoking, and Alcohol
A meta-analysis on the use of GLP-1 receptor agonists in over 30,000 nondiabetic patients with obesity found a significant reduction in blood pressure, mortality, and the risk of myocardial infarction. There was no significant decrease in the risk of stroke, but most probably this is due to the fact that strokes are much less frequent in obesity than in diabetes.
You all know that obesity is also a major risk factor for sleep apnea syndrome. Recently, two large studies with the GIP/GLP-1 receptor agonist tirzepatide found a significant improvement in sleep apnea syndrome compared to placebo, regardless of whether patients needed continuous positive airway pressure therapy or not.
In the therapy studies on diabetes and obesity, there were indications that some smokers in the studies stopped their nicotine consumption. A small pilot study with exenatide in 84 overweight patients who were smokers showed that 46% of patients on exenatide stopped smoking compared with 27% in the placebo group. This could be an indication that GLP-1 receptor agonists have activity on the reward system in the brain. Currently, there are a number of larger placebo-controlled trials ongoing.
Another aspect is alcohol consumption. An epidemiologic study in Denmark using data from the National Health Registry showed that the incidence of alcohol-related events decreased significantly in almost 40,000 patients with diabetes when they were treated with GLP-1 receptor agonists compared with other antidiabetic drugs.
A retrospective cohort study from the United States with over 80,000 patients with obesity showed that treatment with GLP-1 receptor agonists was associated with a 50%-60% lower risk for occurrence or recurrence of high alcohol consumption. There is only one small study with exenatide, which was not really informative.
There are a number of studies underway for GLP-1 receptor agonists compared with placebo in patients with alcohol dependence or alcohol consumption. Preclinical models also indicate that these drugs might be effective in cocaine abuse, and there is one placebo-controlled study ongoing.
Parkinson’s Disease
Let’s come to neurology. Preclinical models of Parkinson’s disease have shown neuroprotective activities of GLP-1. Until now, we have three randomized placebo-controlled trials with exenatide, NLY01, and lixisenatide. Two of these studies were positive, showing that the symptoms of Parkinson’s disease were stable over time and deteriorated with placebo. One study was neutral. This means we need more large-scale placebo-controlled studies in the early phases of Parkinson’s disease.
Another potential use of GIP/GLP-1 receptor agonists is in dementia. These substances, as you know, have positive effects on high blood pressure and vascular risk factors.
A working group in China analyzed 27 studies on the treatment of diabetes. A small number of randomized studies and a large number of cohort studies showed that modern antidiabetic drugs reduce the risk for dementia. The risk reduction for dementia for the GLP-1 receptor agonists was 75%. At the moment, there are only small prospective studies and they are not conclusive. Again, we need large-scale placebo-controlled studies.
The most important limitation at the moment beyond the cost is the other adverse drug reactions with the GLP-1 receptor agonists; these include nausea, vomiting, diarrhea, and constipation. There might be a slightly increased risk for pancreatitis. The US Food and Drug Administration recently reported there is no increased risk for suicide. Another potential adverse drug reaction is nonatherosclerotic anterior optic neuropathy.
These drugs, GLP-1 receptor agonists and GIP agonists, are also investigated in a variety of other non-neurologic diseases. The focus here is on metabolic liver disease, such as fatty liver and kidney diseases. Smaller, positive studies have been conducted in this area, and large placebo-controlled trials for both indications are currently underway.
If these diverse therapeutic properties would turn out to be really the case with GLP-1 receptor agonists, this would lead to a significant expansion of the range of indications. If we consider cost, this would be the end of our healthcare systems because we cannot afford this. In addition, the new antidiabetic drugs and the treatment of obesity are available only to a limited extent.
Finally, at least for neurology, it’s unclear whether the impact of these diseases is in the brain or whether it’s indirect, due to the effectiveness on vascular risk factors and concomitant diseases.
Dr. Diener is Professor in the Department of Neurology, Stroke Center-Headache Center, University Duisburg-Essen, Essen, Germany; he has disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.